Adjuvant administration of probiotic effects on sexual function in depressant women undergoing SSRIs treatment: a double-blinded randomized controlled trial.

BACKGROUND: According to the Institute of Health Metrics and Evaluation's Global Health Data Exchange (2023) it is estimated that 5% of all adults will experience depressive disorder. Amongst the general loss of pleasure and interest in everyday activities that are symptoms of low mood, reduced sexual desire and sexual dysfunction can be particularly overlooked. Human sexuality is complex, but finding solutions based on scientific evidence to limit the symptoms of depressive disorder and the iatrogenic impact of antidepressant treatment to improve this outcome is an important step in promoting psychological health and general wellbeing. OBJECTIVE: The present study aimed is to provide scientific evidence to assess the effect of oral probiotic on sexual function in women with depressive disorder treated with Selective Serotonin Reuptake Inhibitors (SSRIs) in an Iranian population. DESIGN: This study was a double-blind randomized clinical trial. Eligible women were assigned to lactofem plus SSRIs (n = 58) or SSRIs alone (n = 54). In group A, SSRI antidepressants were prescribed together with Lactofem, and in group B, SSRI antidepressants were prescribed alone. Lactofem including Lactobacillus acidophilus 2 × 109 cfu/g, Bifidobacterium bifidus 2 × 109 cfu/g, Lactobacillus rutri 2 × 109 cfu/g, Lactobacillus fermentum 2 × 109 cfu/g; capsule weight of 500 mg bio-capsule administered orally and daily. The duration of intervention in two groups was two months. All questionnaires were completed by the patients before and after the intervention. The Female Sexual Function Index (FSFI), Hamilton Depression Rating Scale and Larson's Sexual Satisfaction Questionnaire were used to evaluate sexual function, severity of depressive disorder and sexual satisfaction, respectively. RESULTS: Based on the results of the present study, there was a statistically significant difference in sexual satisfaction and severity of depressive disorder between the groups before and after the intervention (P < 0.05). Also, our findings showed that after eight weeks, the Lactofem plus SSRIs group showed significant improvement in FSFI domains and total scores compared to SSRIs alone group (P < 0.05). CONCLUSIONS: The results of the present study show that taking probiotics for eight weeks may improve the severity of depressive disorder, sexual function and sexual satisfaction in depressed women treated with SSRIs. TRIAL REGISTRATION: ClinicalTrials.govidentifier: IRCT20160524028038N14 (19/12/2022).

Pregnancy outcomes in pregnant women taking oral probiotic undergoing cerclage compared to placebo: two blinded randomized controlled trial.

AIM: The purpose of this study is to evaluate the oral probiotic effect on pregnancy outcomes in pregnant women undergoing cerclage compared to placebo. METHODS: This study was a double-blind randomized clinical trial undertaken in Yasuj, Iran. 114 eligible participants who have undergone cerclage were randomly divided to either receive probiotic adjuvant or 17α-OHP (250 mg, IM) with placebo from the 16th -37th week of pregnancy by "block" randomization method. Our primary outcomes were preterm labor (PTB) (late and early) and secondary outcomes were other obstetrical and neonatal outcomes included preterm pre-labor rupture of membranes (PPROM), pre-labor rupture of membranes (PROM), mode of delivery, and neonatal outcomes including anthropometric characterize and Apgar score (one and fifth-minute). RESULTS: Results show that there are no statistically significant differences between the two groups in terms of PTB in < 34th (15.51% vs. 17.86%; P = 0.73) and 34-37th weeks of pregnancy (8.7% vs. 16.1%; P = 0.22), and mode of delivery (P = 0.09). PPROM (8.7% vs. 28.5%; P = 0.006) PROM (10.3% vs. 25%; P = 0.04) was significantly lower in patients receiving probiotic adjuvant compared to the control group. After delivery, the findings of the present study showed that there were no significant differences in newborn's weight (3082.46 ± 521.8vs. 2983.89 ± 623.89), head circumstance (36.86 ± 1.53vs. 36.574 ± 1.52), height (45.4 ± 5.34 vs. 47.33 ± 4.92) and Apgar score in one (0.89 ± 0.03 vs. 0.88 ± 0.05) and five minutes (0.99 ± 0.03vs. 0.99 ± 0.03) after birth. CONCLUSION: Our result has shown that the consumption of Lactofem probiotic from the 16th week until 37th of pregnancy can lead to a reduction of complications such as PPROM and PROM.

Comparing pregnancy, childbirth, and neonatal outcomes in women with idiopathic polyhydramnios: a prospective cohort study.

BACKGROUND: In this prospective cohort study, the perinatal outcome in idiopathic polyhydramnios compared with normal pregnancies was examined. METHODS: This was a prospective cohort study of 180 singleton pregnancies who received care at the referral gynecology clinic of Yasuj, Iran between 2018-2020. The inclusion criteria comprised singleton pregnancies, gestational age > 34 weeks; fetuses without structural and chromosomal abnormalities in pregnancy screening test, no maternal diabetes, negative TORCH negative screening test, no Rh factor isoimmunization. Polyhydramnios was defined as: (i) amniotic fluid index ≥ 24 cm; (ii) maximal vertical pocket of ≥ 8 cm. Perinatal outcomes were recorded in both groups. RESULTS: Postpartum hemorrhage (7.8% vs. 2.2; OR: 1.60; 95% CI 1.09-2.34) and cesarean delivery (51.11% vs. 21.11; OR: 1.88; 95% CI 1.42-2.50) and respiratory distress (4.4 v vs. 0; OR: 2.04; 95 C CI 1.75-2.80) was significantly higher in the idiopathic polyhydramnios (P ≤ 0.05) compared to normal pregnancy, which increased with severity of idiopathic polyhydramnios. CONCLUSION: In conclusion, the results of the current study, suggest that idiopathic polyhydramnios may be associated with a higher rate of postpartum hemorrhage, cesarean delivery, and respiratory distress than a normal pregnancy.

Probiotic effects on sexual function in women with polycystic ovary syndrome: a double blinded randomized controlled trial.

BACKGROUND: Considering the presence of sexual dysfunction in patients with polycystic ovary syndrome, our aim was to provide scientific evidence studying effect of oral probiotic on sexual function in patients with PCOS treated with letrozole in an Iranian population. METHODS: This study was a double blind randomized clinical trial. Eligible women were allocated to Lactofem plus letrozole (n = 20) or letrozole (n = 20). Folic acid was prescribed to all participants in two groups during the study. In group A, Lactofem capsule was administered daily for the first month. In the second month, letrozole (2.5 mg daily from the third day of the menstrual cycle for 5 days) plus Lactofem capsule same as previous month were prescribed. In group B, letrozole administered 2.5 days from the third day of the menstrual cycle for 5 days in the second month. All questionnaires were completed by patients after the intervention (two months after the start of treatment). The Female Sexual Function Index (FSFI) and Body Image Concern Inventory (BICI) were used to assess sexual function and body satisfaction, respectively. RESULTS: There is statistically significant increase in chemical pregnancy rate (10% vs. 0%; p = 0.05) and clinical pregnancy (10% vs. 0%; p = 0.05) in Probiotic plus letrozole group compared to letrozole group after intervention. Based on our results, there was a statistically significant difference in each domain and sum score of sexual function of before and after the intervention between group (P < 0.05). Our findings have been shown, after eight weeks, the probiotic plus letrozole group had a significant improvement in the FSFI domains and sum score compared to letrozole alone group. Moreover, there are a significant improvement in mean (IQR) of body image score in probiotic group [30 (4.99) vs. 40 (4.36); P < 0.01]. CONCLUSION: The results of the current study suggests that eight weeks of administration of probiotic may improve chemical and clinical pregnancy rate, sexual function and body satisfaction in women with PCOS.

The effect of Myo-inositol on fertility rates in poor ovarian responder in women undergoing assisted reproductive technique: a randomized clinical trial.

BACKGROUND: Poor ovarian response to gonadotropin is a significant challenge in assisted reproductive technique (ART) and affect 9-24% of ART cycles. This study aimed to evaluate the effect of Myo-inositol on fertility rates in poor ovarian responder women undergoing assisted reproductive technique. METHODS: This study is a double-blinded randomized controlled study that involved 60 poor ovarian responders included in an ICSI program and divided into two groups; intervention group: 30 patients who have been assuming Inofolic (4 g myo-inositol + 400 µg folic acid) for the before the enrollment day; control group: 30 patients assuming folic acid (400 µg) for the same period. Controlled ovarian stimulation was performed in the same manner in the two groups. The main outcomeswere the assessment of oocytes retrievednumber and quality, ovarian sensitivity index,required dose of Gonadotropinsunits × 1000), fertilization rate, biochemical, and clinical pregnancy rate. RESULT: There is no significant difference in clinical characteristics between study groups. The number of oocytes retrieved, number of MII oocytes, number of embryos transferred, chemical, and clinical pregnancy were higher in the intervention group. However, they are not statistically significant in comparison to the control group. The ovarian sensitivity index and fertilization rate were significantly higher in the intervention group than the control group (P > 0.05). The required dose of gonadotropin significantly lower in the intervention group than the control group. CONCLUSION: Our results suggest that the supplementation myo-inositol in poor ovarian responders significantly improved the ART outcomes such as fertilization rate gonadotropin, ovarian sensitivity index (OSI) and significantly reduced the required unities of gonadotropin. Additionally, more extensive randomized controlled studies are needed. TRIAL REGISTRATION: Iranian Registry of Clinical Trials, IRCT20180515039668N1 , retrospectively registered since 2020-03-16.

Does vitamin D supplementation improve ovarian reserve in women with diminished ovarian reserve and vitamin D deficiency: a before-and-after intervention study.

OBJECTIVE: Evaluation of vitamin D supplementation on ovarian reserve in women with diminished ovarian reserve and vitamin D deficiency. METHODS: The study is a before-and-after intervention study that was performed on women with diminished ovarian reserve referred to Shahid Mofteh Clinic in Yasuj, Iran. Eligible women were prescribed vitamin D tablets at a dose of 50,000 units weekly for up to 3 months. Serum levels of vitamin D and AMH were evaluated at the end of 3 months. Significance level was also considered P ≤ 0.05. RESULTS: Our results have been showed there was a statistically significant difference in vitamin D levels of participants before [12.1(6.5)] and after [26(9.15)] the intervention (P < 0.001). Moreover, there was a statistically significant difference in serum AMH levels of participants before [0.50(0.44)] and after [0.79(0.15)] the intervention (P=0.02 ). CONCLUSION: In conclusion, the results of the current study support a possible favorable effect of vitamin D on increase AMH expression by acting on the AMH gene promoter. Therefore, it is possible that vitamin D increases AMH levels without changing the antral follicle count/ovarian reserve.

Pharmacological and non-pharmacological strategies for obese women with subfertility.

BACKGROUND: Clinicians primarily recommend weight loss for obese women seeking pregnancy. The effectiveness of interventions aimed at weight loss in obese women with subfertility is unclear. OBJECTIVES: To assess the effectiveness and safety of pharmacological and non-pharmacological strategies compared with each other, placebo, or no treatment for achieving weight loss in obese women with subfertility. SEARCH METHODS: We searched the CGF Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, and AMED from inception to 18 August 2020. We also checked reference lists and contacted experts in the field for additional relevant papers. SELECTION CRITERIA: We included published and unpublished randomised controlled trials in which weight loss was the main goal of the intervention. Our primary effectiveness outcomes were live birth or ongoing pregnancy and primary safety outcomes were miscarriage and adverse events. Secondary outcomes included clinical pregnancy, weight change, quality of life, and mental health outcome. DATA COLLECTION AND ANALYSIS: Review authors followed standard Cochrane methodology. MAIN RESULTS: This review includes 10 trials. Evidence was of very low to low quality: the main limitations were due to lack of studies and poor reporting of study methods. The main reasons for downgrading evidence were lack of details by which to judge risk of bias (randomisation and allocation concealment), lack of blinding, and imprecision. Non-pharmacological intervention versus no intervention or placebo Evidence is insufficient to determine whether a diet or lifestyle intervention compared to no intervention affects live birth (odds ratio (OR) 0.85, 95% confidence interval (CI) 0.65 to 1.11; 918 women, 3 studies; I² = 78%; low-quality evidence). This suggests that if the chance of live birth following no intervention is assumed to be 43%, the chance following diet or lifestyle changes would be 33% to 46%. We are uncertain if lifestyle change compared with no intervention affects miscarriage rate (OR 1.54, 95% CI 0.99 to 2.39; 917 women, 3 studies; I² = 0%; very low-quality evidence). Evidence is insufficient to determine whether lifestyle change compared with no intervention affects clinical pregnancy (OR 1.06, 95% CI 0.81 to 1.40; 917 women, 3 studies; I² = 73%; low-quality evidence). Lifestyle intervention resulted in a decrease in body mass index (BMI), but data were not pooled due to heterogeneity in effect (mean difference (MD) -3.70, 95% CI -4.10 to -3.30; 305 women, 1 study; low-quality evidence; and MD -1.80, 95% CI -2.67 to -0.93; 43 women, 1 study; very low-quality evidence). Non-pharmacological versus non-pharmacological intervention We are uncertain whether intensive weight loss interventions compared to standard care nutrition counselling affects live birth (OR 11.00, 95% CI 0.43 to 284; 11 women, 1 study; very low-quality evidence), clinical pregnancy (OR 11.00, 95% CI 0.43 to 284; 11 women, 1 study; very low-quality evidence), BMI (MD -3.00, 95% CI -5.37 to -0.63; 11 women, 1 study; very low-quality evidence), weight change (MD -9.00, 95% CI -15.50 to -2.50; 11 women, 1 study; very low-quality evidence), quality of life (MD 0.06, 95% CI -0.03 to 0.15; 11 women, 1 study; very low-quality evidence), or mental health (MD -7.00, 95% CI -13.92 to -0.08; 11 women, 1 study; very low-quality evidence). No study reported on adverse events . Pharmacological versus pharmacological intervention For metformin plus liraglutide compared to metformin we are uncertain of an effect on the adverse events nausea (OR 7.22, 95% CI 0.72 to 72.7; 28 women, 1 study; very low-quality evidence), diarrhoea (OR 0.31, 95% CI 0.01 to 8.3; 28 women, 1 study; very low-quality evidence), and headache (OR 5.80, 95% CI 0.25 to 133; 28 women, 1 study; very low-quality evidence). We are uncertain if a combination of metformin plus liraglutide vs metformin affects BMI (MD 2.1, 95% CI -0.42 to 2.62; 28 women, 1 study; very low-quality evidence) and total body fat (MD -0.50, 95% CI -4.65 to 3.65; 28 women, 1 study; very low-quality evidence). For metformin, clomiphene, and L-carnitine versus metformin, clomiphene, and placebo, we are uncertain of an effect on miscarriage (OR 3.58, 95% CI 0.73 to 17.55; 274 women, 1 study; very low-quality evidence), clinical pregnancy (OR 5.56, 95% CI 2.57 to 12.02; 274 women, 1 study; very low-quality evidence) or BMI (MD -0.3, 95% CI 1.17 to 0.57, 274 women, 1 study, very low-quality evidence). We are uncertain if dexfenfluramine versus placebo affects weight loss in kilograms (MD -0.10, 95% CI -2.77 to 2.57; 21 women, 1 study; very low-quality evidence). No study reported on live birth, quality of life, or mental health outcomes. Pharmacological intervention versus no intervention or placebo We are uncertain if metformin compared with placebo affects live birth (OR 1.57, 95% CI 0.44 to 5.57; 65 women, 1 study; very low-quality evidence). This suggests that if the chance of live birth following placebo is assumed to be 15%, the chance following metformin would be 7% to 50%. We are uncertain if metformin compared with placebo affects gastrointestinal adverse events (OR 0.91, 95% CI 0.32 to 2.57; 65 women, 1 study; very low-quality evidence) or miscarriage (OR 0.50, 95% CI 0.04 to 5.80; 65 women, 1 study; very low-quality evidence) or clinical pregnancy (OR 2.67, 95% CI 0.90 to 7.93; 96 women, 2 studies; I² = 48%; very low-quality evidence). We are also uncertain if diet combined with metformin versus diet and placebo affects BMI (MD -0.30, 95% CI -2.16 to 1.56; 143 women, 1 study; very low-quality evidence) or waist-to-hip ratio (WHR) (MD 2.00, 95% CI -2.21 to 6.21; 143 women, 1 study; very low-quality evidence). Pharmacological versus non-pharmacological intervention No study undertook this comparison. AUTHORS' CONCLUSIONS: Evidence is insufficient to support the use of pharmacological and non-pharmacological strategies for obese women with subfertility. No data are available for the comparison of pharmacological versus non-pharmacological strategies. We are uncertain whether pharmacological or non-pharmacological strategies effect live birth, ongoing pregnancy, adverse events, clinical pregnancy, quality of life, or mental heath outcomes. However, for obese women with subfertility, a lifestyle intervention may reduce BMI. Future studies should compare a combination of pharmacological and lifestyle interventions for obese women with subfertility.

Hospital discharge on the first compared with the second day after a planned cesarean delivery had equivalent maternal postpartum outcomes: a randomized single-blind controlled clinical trial.

OBJECTIVE: Determining the effect of discharge time after elective cesarean section on maternal outcomes. METHODS: This study is a randomized clinical trial that performed on 294 women who undergo elective cesarean section. The patients were randomized in two groups by simple randomization method: Group A (discharge 24 h after cesarean) and group B (discharge for 48 h after cesarean). In both groups, during the first 24 h, they received intravenous antibiotic (cefazolin as routine order) and pethidine at the time of pain. The patients were discharged with the hematinic and mefenamic acid. The main outcome variables were satisfaction of the patient, surgical site infection, separation of incision, endometritis, urinary tract infection, gastrointestinal complications, rehospitalization, secondary postpartum hemorrhage and pain of the patient on discharge day, one and six weeks after cesarean. RESULTS: Satisfaction scores and pain score at discharge day, one and six weeks after discharge were not significant different in the study groups (P > 0.05). Another key finding of this paper was no significant difference in the incidence of surgical site infection, separation of incision, endometritis, urinary tract infection, gastrointestinal complications, rehospitalization, secondary postpartum hemorrhage at one and six weeks after discharge in the study groups(P > 0.05). CONCLUSION: The time of discharge can be reduced to 24 h after surgery if the mother to be at good general condition, the vital signs are stable, the patient has no underlying problem and disease, and it is financed for the patient and the health system.

Obstetric, maternal, and neonatal outcomes in COVID-19 compared to healthy pregnant women in Iran: a retrospective, case-control study.

BACKGROUND: The purpose of the present study was to evaluate obstetric, maternal, and neonatal outcomes in COVID-19 compared to healthy pregnant women in Iran. RESULTS: A case-control study was conducted on 55 COVID-19 as the case and 55 matched control pregnant women in Hormozgan, Iran. Patients were considered to be cases if they had a positive COVID-19 test plus a positive chest X-ray result. Our measures were COVID-19 symptoms, including laboratory evaluations, clinical symptoms, and maternal and neonatal outcomes.The most prevalent symptoms related to COVID-19 were fever (69.09%) and cough (58.18%). Less common symptoms included fatigue, diarrhea, shortness of breath, sore throat, and myalgia. Hydroxychloroquine/chloroquine (58.18%) and antibiotic therapy (45.45%) were the most prevalent management in COVID-19 patients. Based on our findings, maternal and obstetric outcomes-neonatal in case groups-such as mode of delivery, premature rupture of membrane, postpartum hemorrhage, perineal resection rate, neonates' birth weight, Apgar score, and neonatal asphyxia rate were similar to pregnant women without COVID-19. We observed a higher incidence rate of premature delivery in COVID-19 cases (25 vs. 10%) (p < 0.05). In the present study, we found that women with COVID-19 had a more than twofold increased odds of preterm labor. History of preterm delivery was also associated with high twofold odds of preterm labor. CONCLUSION: We observed a higher incidence rate of premature delivery in COVID-19 cases. Women with COVID-19 had a more than twofold increased odds of preterm labor. Considering prematurity has high morbidity and is regarded as the primary cause of mortality in children under 5 years old, more case-control studies are needed to ascertain the results.

The impact of irritable bowel syndrome on health-related quality of life in women with polycystic ovary syndrome.

BACKGROUND: The objectives of this study were to compare the prevalence and quality of life (QOL) of irritable bowel syndrome (IBS) in women with polycystic ovary syndrome (PCOS) compared with healthy women. METHODS: This was a case-control study of 201 women recruited at an infertility clinic in Iran. The control group were healthy women (n = 100) and the comparison group, women with PCOS (n = 101). Data were collected by clinical Rome III criteria to determine the IBS, Bristol scale for stool consistency and IBS QOL. RESULTS: The reporting of IBS symptoms were higher in PCOS (20.7%) than control group (11%) (P = 0.05). The IBS QOL score in the IBS + PCOS group was lower than other groups (IBS+ non PCOS, non IBS + PCOS, non IBS+ non PCOS; scores in food avoidance and worries about health domains were significant (P < 0.01). CONCLUSIONS: We conclude that having PCOS and an increased level of LH/FSH tends to cause IBS symptoms. IBS + PCOS women experience significant impaired quality of life scores particularly in relation to worries about health and food avoidance. These results offer further insights into IBS in PCOS women and their functional status and wellbeing.

The impact of depression, self-esteem, and body image on sleep quality in patients with PCOS: a cross-sectional study.

BACKGROUND: To date, some factors associated with quality of sleep in patients with PCOS have been identified. Previous studies have mainly focused on limited psychological variables related to sleep disorder without evaluating them in a comprehensive framework. OBJECTIVE: The aim of the present study was to evaluate the impact of predictive factors on the sleep quality of PCOS patients using structural equation modeling (SEM). MATERIAL AND METHODS: The present study is a case control that is done in an infertility clinic in Hormozgan, Iran. The case group (n = 201) consisted of women with PCOS and the control group (n = 199) was healthy women whose partners had male infertility. All the women recruited to the study completed the Hospital Anxiety and Depression Scale, the Body Image Concern Investigation, the Rosenberg Self-esteem Scale, and the Pittsburgh Sleep Quality Index on attendance at the Hormozgan Infertility Clinic. Direct and indirect relationship between clinical signs, psychological situation, self-esteem, and body image was studied as independent predictors of sleep quality using structural equation modeling. RESULTS: Compared with the control group, there was a lower sleep quality in women with PCOS in all fields, especially subjective sleep quality (P < 0.05), daytime function (P = 0.001), and use of sleep medication (P = 0.003). The strongest effect from a psychological variable on sleep quality was body image which had negative impact on sleep quality of patients with PCOS. CONCLUSION: Our study showed that body image plays an important role in the sleep quality of women with PCOS.

Comparing pregnancy, childbirth, and neonatal outcomes in women with different phenotypes of polycystic ovary syndrome and healthy women: a prospective cohort study.

The aim of this study was to compare pregnancy, childbirth, and neonatal outcomes in women with different phenotypes of polycystic ovary syndrome (PCOS) with healthy women. A prospective cohort study from the beginning to the end of pregnancy for 41 pregnant women with PCOS (case) and 49 healthy pregnant women (control) was completed. Based on the presence or absence of menstrual dysfunction (M), hyperandrogenism (HA), and polycystic ovaries (PCO) on ultrasound, the PCOS (case) group were divided into three phenotypes (HA + PCO (n = 22), M + PCO (n = 9), HA + M+PCO (n = 10). Pre-eclampsia, gestational diabetes, and lower birth weight among newborns were significantly higher in the PCOS case group compared to the control group especially in the phenotype HA + M+PCO (p < .05). High BMI (ß = 2.40; p=.03) was the strongest predictor of pre-eclampsia in patients with PCOS. High androgen levels (free androgen index) (ß = 13.71, 3.02; p < .05), was the strongest predictor of developing diabetes during pregnancy and reduced birth weight baby, respectively.These results suggest that PCOS, particularly in phenotype HA + M+PCO (p < .05), is a risk factor for adverse pregnancy and neonatal outcomes including gestational diabetes, pre-eclampsia, and reduced weight babies.

The effectiveness of inositol and metformin on infertile polycystic ovary syndrome women with resistant to letrozole.

PURPOSE: The purpose is a comparison of effectiveness of myo-inositol and metformin in infertile women with polycystic ovary syndrome (PCOS) treated with letrozole. METHODS: This study is a randomized single-blind controlled clinical trial undertaken in 150 infertile PCOS women. For all patients, letrozole is prescribed at a dose of 7.5 mg per day from the third day of menstruation for 5 days. Patients who did not ovulate were included and divided into three pretreatment groups: group I(control group), 200 µg of folic acid (as a placebo); group II, 1500 mg of metformin daily plus 200 µg of folic acid, and group III, inositol 2 g plus 200 µg of folic acid received twice daily for 3 months. In the last cycle, 7.5 mg letrozole was prescribed for the induction of ovulation. Primary outcomes were ovary function and pregnancy. RESULTS: The ovarian function was not significantly different in those groups, whereas the ovarian function of inositol + folic acid group in normal BMI found significantly higher than other BMI spectra. In addition, the ovarian function is significantly higher in the inositol + folic acid group by increasing the infertility duration. The incidence of pregnancy is lower in letrozole + folic acid + inositol group than the other groups; however, it is not significant. CONCLUSION: The addition of inositol and metformin to the treatment of infertile PCOS women with letrozole resistance improves the ovarian function; however, it is not significant. Of note, inositol was more effective than metformin in patients with normal BMI. IRCT REGISTRATION NUMBER: IRCT2017070234845N1.

Health-related quality of life in Iranian women with polycystic ovary syndrome: a qualitative study.

BACKGROUND: Polycystic ovary syndrome (PCOS) is associated with a range of challenging symptoms which impact patient's lives. Iranian women with PCOS are likely to face a number of unique difficulties given particular societal and cultural norms for women. Understanding health-related quality of life (HRQoL) from a patients'perspective is critical to developing the appropriate support interventions. The present study aimed to generate an in-depthunderstanding of HRQoL Iranian women with PCOS. METHODS: Twenty Iranian women were interviewed and data was subjected to thematic analysis. RESULTS: Women reported substantial effects of PCOS on their quality of life, Themes generated from the data related to sexual - physical problems (An unsexualised self: loss, change and pain; and Being pained and painful); exposure and nvasion: the rejecting and invading social world (Concealing and Avoiding and Public property: public scrutiny), diminished self and diminished life (Infertile as inferior and Exhausted mind andbody) respectively. CONCLUSION: PCOS is a physical - sexual, psychological and social syndrome; therefore, it is necessary to taking a more holistic approach to patient care beyond treating physical symptoms.

Health-related quality of life in patients with polycystic ovary syndrome (PCOS): a model-based study of predictive factors.

INTRODUCTION: Understanding the factors that contribute to health-related quality of life (HRQOL) is critical for developing the most appropriate interventions for improving or maintaining the HRQOL in polycystic ovary syndrome (PCOS) patients. AIM: This study sought to determine the most significant predictors of the HRQOL in patients with PCOS. METHODS: This was a cross-sectional study of 300 women with PCOS that was carried out in Kashan, Iran. A sample of women with PCOS was entered into the study and completed the following questionnaires: the Hospital Anxiety and Depression Scale, the Body Image Concern Inventory (BICI), the Rosenberg's Self-Esteem Scale score, the modified polycystic ovary syndrome health-related quality of life questionnaire, the Female Sexual Function Index. MAIN OUTCOME MEASURE: Both direct and indirect relationships among clinical severity, psychological status, self-esteem, body image, and sexual function as independent predictors of HRQOL were examined using structural equation modeling (SEM) analysis. By using the SEM, we simultaneously test a number of possible hypotheses concerning the interrelations among the predictors of HRQOL in PCOS patients. RESULTS: In relation with severity of PCOS, reproductive history and menstrual status explained a high proportion of the variance of clinical variables (factor loading 0.37 and 0.34, respectively). The highest effect on HRQL was exerted by indirect effect of clinical factor (ß = 0.90), self-esteem (ß = 1.12), body image (ß = 1.06), and sexual function (ß = 0.26) that influenced negatively HRQOL. The infertility and menstrual domains were the most affected areas of HRQOL. In relation with sexual dysfunction, the most affected domains were desire and arousal. CONCLUSION: The highest effect of PCOS symptoms on HRQOL impairment among patients was exerted by self-esteem, body image, and sexual dysfunction. With regard to HRQOL in clinical routine, we conclude these mediating factors should be taken into consideration and adequately treated if present.

Psychological investigation in patients with polycystic ovary syndrome.

BACKGROUND: The aim of the present study was to estimate the prevalence of mood disorders and examine a range of predictors for psychological well-being among Iranian women with polycystic ovary syndrome (PCOS). METHODS: A cross-sectional study was undertaken to ascertain the factors related to psychological distress in PCOS patients in Kashan, Iran. Psychological distress was measured using the Hospital Anxiety and Depression Scale (HADS). In addition we assessed quality of life using the Short Form Health Survey (SF-36). Socio-demographic details and clinical information of PCOS including obesity (body mass index), excessive body hair (hirsutism score), acne, menstrual cycle disturbances, infertility and endocrine profile also were recorded for each patient. RESULTS: In all 300 women with PCOS were entered into the study. Of these 32% (n =96) showed elevated HADS anxiety while depression was high in 5% (n =15). Quality of life was significantly impaired in women with anxiety (P <0.05), and depression (P <0.001) and in particular, in women with coexistence anxiety and depression (P <0.001) compared with unaffected participants. Compared with the non-depressed PCOS patients, the depressed women had significantly higher menstrual irregularities (P = 0.008). Moreover, we found significant difference in FAI level between the depressed and non depressed (p = 0.05), the anxious and non anxious patients (p < 0.001) compare to non affected PCOS women. CONCLUSIONS: The high prevalence of depression and anxiety in this population suggests that initial evaluation of all women with PCOS should also include assessment of mental health disorders. The clinician should further pay attention to background of their patients especially in view of the factors influencing psychological well-being.

Psychometric properties of the Iranian version of modified polycystic ovary syndrome health-related quality-of-life questionnaire.

STUDY QUESTION: Can the modified polycystic ovary syndrome health-related quality-of-life questionnaire (MPCOSQ) be validated in Iranian patients with polycystic ovary syndrome (PCOS) to provide an instrument for future outcome studies in these patients? SUMMARY ANSWER: We show initial reliability and validity of the Iranian version of the MPCOSQ as a specific instrument to measure health-related quality of life (QOL) in patients with PCOS in Iran. WHAT IS KNOWN ALREADY: The prevalence of PCOS in Iran is relatively high and studying QOL in these patients is important. The PCOSQ has previously been translated and validated in Iran but no studies had examined the psychometric properties of the MPCOSQ in Iran. STUDY DESIGN, SIZE, AND DURATION: This was a cross-sectional study. After linguistic validation of the Iranian version of MPCOSQ, an expert panel evaluated the items by assessing the content validity index (CVI) and content validity ratio (CVR). Then a semi-structured interview was conducted to assess face validity. Consequently, exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were performed to indicate the scale constructs (n = 200). In addition, reliability analyses including internal consistency and test-retest analysis were carried out. PARTICIPANTS/MATERIALS, SETTING, AND METHODS: This study was carried out on women with PCOS (n = 200) who attended two private gynecology clinics in Kashan, Iran. Patients were eligible if they met each of the following criteria: 15-40 years of age; married; not having non-classic adrenal hyperplasia, thyroid dysfunction and hyperprolactinemia; Iranian; not having problems in speaking or listening; having two of the following Rotterdam diagnostic criteria: (i) polycystic ovaries visualized on ultrasound scan (presence of 12 follicles or more in one or both ovaries and/or increased ovarian volume >10 ml), (ii) clinical signs of hyperandrogenism (the hirsutism score based on the Ferriman-Gallwey score >7 or obvious acne) and/or an elevated plasma testosterone (normal range testosterone <2 nmol/l), (iii) having an interval between menstrual periods >35 days and/or amenorrhea as the absence of vaginal bleeding for at least 6 months, i.e. 199 days. MAIN RESULTS AND THE ROLE OF CHANCE: CVI and CVR scores for MPCOSQ were 0.96 and 0.92, respectively. A six-factor solution (emotional disturbance, weight, infertility, acne, menstrual difficulties and hirsutism) emerged as a result of an EFA and explained 0.64% of the variance observed. The result of the EFA supported the item 'late menstrual period' being placed in the menstrual rather than the emotional subscale. The results of the CFA for six-factor model for MPCOSQ indicated an acceptable fit for the proposed model. Additional analyses indicated satisfactory results for internal consistency (Cronbach's alpha ranging from 0.76 to 0.92) and intraclass correlation coefficients (ranging from 0.71 to 0.92). Moving 'late menstrual period' from the emotional to the menstrual subscale significantly improved the reliability coefficient for both subscales. LIMITATIONS, REASONS FOR CAUTION: Study of patients with PCOS attending two private gynecology clinics may limit generalization of the findings to the entire population with PCOS. All patients in this study were married for cultural reasons in Iran. Therefore, the results of the present study have to be interpreted with some caution. WIDER IMPLICATIONS OF THE FINDINGS: The Iranian version of the MPCOSQ will fill an important gap in measuring the QOL in patients with PCOS in the research and community settings in Iran.

Effect of Acupressure on Health-Related Quality of Life in Patients with Polycystic Ovarian Syndrome: A Randomized Clinical Trial.

The present study was conducted to determine the effect of acupressure on health-related quality of life in patients with polycystic ovary syndrome. This study was a double-blind, randomized clinical trial with a control group. Ninety-six patients with polycystic ovary syndrome from Mofateh gynecological clinic in Yasuj in Iran were enrolled according to the inclusion criteria. Patients were randomly assigned to intervention and control groups. In the intervention group, pressure on the points, Ren3, Ren4, Liv3, Sp6, and Sp10 and in the control group, pressure on sham points were performed for 6 weeks (2 sessions per week). The primary outcome was health-related quality of life, measured by the modified polycystic ovary syndrome health-related quality of life questionnaire (MPCOSQ). The secondary outcomes were total testosterone levels and clinical symptoms in patients with polycystic ovary syndrome. The outcome variables were measured before the intervention at week 0 (baseline) and after the intervention at week 18 (12 weeks after the end of intervention). The results indicated that at week 18, the score of clinical symptoms and the total testosterone level of the intervention group were lower than those of the control group. The health-related quality of life score in the intervention group was higher than that in the control group, which was statistically significant (P < 0/05). Therefore, acupressure in these points is recommended as a practical and effective method of treating polycystic ovarian syndrome.

Effects of Boiled Dill Seed on Anxiety During Labor: A Randomized Clinical Trial.

OBJECTIVE: To evaluate the effect of boiled dill seed (Anethum graveolens) on anxiety during childbirth compared with oxytocin. METHODS: This study was a randomized clinical trial with 100 pregnant women who were assigned to the oxytocin (50 cases) and the boiled dill seed (50 cases) group by a table of random number. In the boiled dill seed group, 10 g of dill seed was boiled in 100 mL for 10 min and was given to women after filtration once orally at the beginning of active phase. In the oxytocin group, 10 IU of oxytocin in 1000 mL of Ringer solution was prescribed according to the clinical routine. The State-Trait Anxiety Inventory (STAI) in both groups before (at the beginning of the active phase) and after (6 h after the delivery) was completed. Meanwhile, pain intensity and duration of labor, dilatation and effacement scores, Apgar score of newborns, and FHR were measured and evaluated. RESULTS: No statistically significant differences were shown in obvious anxiety scores between the two groups at baseline (P0.05). After the delivery, in the boiled dill seed group, the number of women with severe [0 vs. 8.0% (4/50)] and almost severe [0 vs. 14.0% (7/50)] trait and almost severe [0 vs. 14.0% (7/50)] state anxiety was lower than those in the control group (P=0.050, P=0.041, respectively). Moreover, labor was shorter in the 1st (P 0.01), 2nd (P=0.78) and 3rd (P=0.10) stages in the boiled dill seed group compared to the control group CONCLUSIONS: Dill seed could be used as an effective treatment to reduce anxiety during labor. Dill seed can be effective in reducing the length of labor. Due to lack of maternal and fetal complications, the boiled dill seed could also be used to reduce cesarean section rates in women who are fearful and anxious of delivery. (RCT Code: IRCT201607177065N2).

Psychometric properties of the Farsi version of the women's perceptions of vaginal examination during labor questionnaire.

BACKGROUND: Vaginal examination is the essential part of obstetric care in women's life. Although the assessment of women's perceptions of vaginal examination is important, no appropriate instrument in Farsi is available. Therefore, the present study was conducted to evaluate validity and reliability of the Farsi version of the women's perceptions of vaginal examination during labor questionnaire. MATERIALS AND METHODS: This cross-sectional study was carried out with 350 women who had vaginal childbirth between December 2016 and May 2017. The women were asked to fill out the demographic characteristics' form and the women's perceptions of vaginal examination during labor questionnaire. Construct validity, internal consistency, and stability of the questionnaires were evaluated using confirmatory factor analysis, calculation of the Cronbach's alpha coefficient, and Spearman-Brown correlation coefficient, respectively. The SPSS (Statistical Package for the Social Sciences) v. 21 and LISREL (linear structural relations) 8.80 were used for the data analysis. RESULTS: Confirmatory factor analysis indicated that the Farsi version of the women's perceptions of vaginal examination during labor questionnaire had appropriate structure. The Cronbach's alpha coefficient of the questionnaire was reported as 0.76. The Spearman-Brown correlation coefficient also showed an appropriate test-retest reliability. CONCLUSION: Validity and reliability of this questionnaire can appropriately measure the women's perceptions of vaginal examination during labor among Iranian women.