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.

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).

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.

Granulocyte colony stimulating factor (GCSF) did not affect the fertility outcomes in women with unexplained infertility after intrauterine insemination: a randomised clinical trial.

This study aimed to evaluate the effect of granulocyte colony stimulating factor (GCSF) on fertility outcomes in women with unexplained infertility after intrauterine insemination (IUI). This study is a randomised clinical trial that was conducted on unexplained infertile women referred to infertility Clinic in Yasuj, Iran. All participants were stimulated by letrozole, clomiphene and HMG during the cycle. When at least one follicle was greater than 18 mm, 5000 IU hCG intramuscularly was administered for ovulation induction and then IUI was performed 34-36 hours later. In GCSF group, 300 µg GCSF subcutaneously administrated in two days after IUI. Control group received routine IUI. The main outcome measures were biochemical pregnancy, clinical pregnancy, abortion and ongoing pregnancy rate. Our results showed no statistically significant difference in the biochemical pregnancy (16.3% vs. 12.2%; P=.56), clinical pregnancy (16.3% vs. 8.2%; P=.21), abortion (0 vs. 2.04%; P=.55) and ongoing pregnancy rates (8.2% vs. 14.2%; P=.32) between the control and the G-CSF groups. The results of the current study suggest that systemic administration of 300 µg GCSF in the two days after receiving IUI in patients with unexplained infertility does not offer any beneficial clinical related implantation, and pregnancy rates. IRCT registration number: IRCT20160524028038N4 Impact statementWhat is already known on this subject? Unexplained infertility means to the inability of couples in pregnancy after a year without obvious male and female infertility factors. Some patients have not been justified in endometrial function, which leads to the defect of the dialogue between the foetus and endometrium and may lead to implantation failure. Granulocyte colony stimulating factor is produced at the maternal-foetal interface during embryo implantation and is the main part of the uterine-cytokine network that is needed to create and maintain pregnancy.What do the results of this study add? The current study suggests that systemic administration of 300 µg granulocyte colony stimulating factor in the two days after receiving IUI in patients with unexplained infertility does not offer any beneficial clinical related implantation and pregnancy rates.What are the implications of these findings for clinical practice and/or further research? These results may not be generalised to all patients and more randomised controlled trials are needed for the comparison of granulocyte colony stimulating factor effects on women with thin and normal endometrial thickness, efficacy, side effects, and pregnancy outcomes of the intrauterine perfusion versus systemic subcutaneous administration of granulocyte colony stimulating factor in unexplained infertility treated with intrauterine insemination.

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 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.

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.

Detailed Investigation of Downstream TLR Signaling in the Follicular Cells of Women with Endometriosis.

BACKGROUND: Inflammatory responses within the peritoneal cavity may result in endometrial dysfunction in women with endometriosis. The true causes of this disease remain poorly understood. It is hypothesized that downstream toll-like receptors (TLRs) inflammatory cytokines in response to pathogens may be associated with endometriosis. So, this study was aimed at evaluating the expression of TLRs signaling and endometriosis-associated inflammatory responses. METHODS: Totally, 20 infertile endometriosis patients and 20 normal women undergoing controlled ovarian stimulation were enrolled. The cellular pellet and supernatant were obtained by centrifugation of follicular fluid (FF). Evaluation of TLRs and their signaling pathway gene expression was performed on cellular pellets using quantitative-PCR. The supernatant was used for determination of cytokine protein expression by ELISA. The results are expressed as mean±SEM and a p<0.05 was considered statistically significant. RESULTS: Quantitative-PCR analysis suggested that TLR1, 5, 6, 7, 8, 10, MYD88, NF-ĸB, IL-10 and TGF-ß genes expression significantly increased in patients compared to the control group (p<0.05). TLR3, 9, INF-ß genes expression was significantly lower in endometriosis than control group (p<0.05). There was no significant difference in the expression of TLR2, TLR4, TIRAP, TRIF, TRAM, and IRF3 between two groups. Also, significant increase in the levels of IL-6, IL-8 and MIF protein in FF of endometriosis group was detected in comparison with normal women (p<0.05). CONCLUSION: The expression of TLR downstream signaling in the follicular cells can initiate inflammatory responses and changes in the FF cytokine profile which in turn may induce endometriosis and infertility disorder.

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.

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 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.

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.

Psychometrics properties of the Iranian version of fertility quality of life tool: A cross- sectional study.

BACKGROUND: Clinical measurement of quality of life (QoL) for assessing reproductive problems should be considered as a standard investigation at the initial and continuing medical consultations with infertile people. OBJECTIVE: The purpose of this study was comprehensive testing the psychometric properties of the Iranian version of fertility quality of life (FertiQoL). MATERIALS AND METHODS: This cross-sectional study was conducted on300 women referred to infertility clinic. After linguistic validation, a semi-structured interview was conducted to assess face validity. Consequently exploratory factor analysis was performed to indicate the scale constructs. Discriminate validity was assessed using the known groups comparison. Convergent validity was evaluated by assessing the correlation between similar content on the 12-Item Short Form Health Survey (SF12), Hospital Anxiety and Depression Scale and FertiQol. In addition, reliability analysis was carried out with internal consistency. RESULTS: The reliability of the Iranian version of the FertiQoL was satisfactory in all dimensions (0.77-0.83). Six factors (emotional, mind/body, relational, social, environmental, and tolerability) were extracted from the results of exploratory factor analysis. Discrimination validity showed that FertiQoL can differentiate between female patients with differing duration of infertility and number of children. Moreover, the results of convergent validity showed a favorable correlation between the related dimensions of SF12 (0.43-0.68), Hospital Anxiety and Depression Scale (0.47-0.52) and FertiQoL. CONCLUSION: The Iranian version of FertiQoL is valid and reliable for assessing infertility problems and the effects of treatment on QoL of infertile patients referred for diagnosis and treatment at infertility clinic.

A randomized controlled clinical trial evaluating quality of life when using a simple acupressure protocol in women with primary dysmenorrhea.

OBJECTIVE: To evaluate a simple acupressure protocol in LIV3 and LI4 acupoints in women with primary dysmenorrhea. METHODS: This paper reports a randomized, single blinded clinical trial. 90 young women with dysmenorrhea were recruited to three groups to receive 20min acupressure every day in either LIV3 or LI4, or placebo points. Acupressure was timed five days before menstruation for three successive menstrual cycles. On menstruation, each participant completed the Wong Baker faces pain scale, and the quality of life short form -12 (QOL SF-12). RESULTS: Intensity and duration of pain between the three groups in the second and third cycles during the intervention (p<0.05) differed significantly. Significant differences were seen in all domains of QOL except for mental health (p=0.4), general health (p=0.7) and mental subscale component (p=0.12) in the second cycle, and mental health (p=0.9), and mental subscale component (p=0.14) in the third cycle. CONCLUSION: Performing the simple acupressure protocol is an effective method to decrease the intensity and duration of dysmenorrhea, and improve the QOL. Registration ID in IRCT: IRCT2016052428038N1.

Pelvic floor dysfunction and polycystic ovary syndrome.

The purpose of this study was to compare the prevalence of pelvic floor dysfunction (PFD) symptoms in patients with and without polycystic ovary syndrome (PCOS) and among different PCOS phenotypes. This was a case-control study. All participants were assessed using ultrasonography to determine the presence or absence of polycystic ovaries (PCO) and allocated to the case or control group (having healthy females whose husbands were diagnosed with male infertility). The case group was then further subdivided into the three phenotypes according to the presence or absence of menstrual dysfunction (M), hyperandrogenism (HA) and PCO on ultrasonography. Pelvic floor dysfunction was assessed by the Pelvic Floor Distress Inventory-20 (PFDI-20). Briefly, the reported pelvic organ prolapse (POP) symptoms were higher in PCOS group (p = 0.05). The mean PFD score in the HA + M + PCO group was higher compared to other phenotypes although the difference did not reach significant level (p > 0.05). However, there was a significant positive correlation between luteinising hormone (LH) level and the POP symptom portion of the PFDI-20 (p < 0.05). The reported POP symptoms were higher in PCOS group especially in HA + M + PCO phenotype. The findings suggest that higher levels of LH might correlate to symptoms of POP.

The effect of applying pressure to the LIV3 and LI4 on the symptoms of premenstrual syndrome: A randomized clinical trial.

OBJECTIVE: To evaluate the effect of simple acupressure protocol in LIV3, LI4 and placebo points on the quality of life (QOL) in women with premenstrual syndrome (PMS). METHOD: This paper reports a randomized, single blinded clinical trial. 97 participants (students in of Hormozgan University of Medical Sciences, Iran) with PMS were allocated to three groups to receive 20min acupressure on different acupoints for 14days before menstruation for three consecutive menstrual cycles (training and then two cycles self applied acupressure). The acupoints were LIV3 and LI4; one group received acupressure at a placebo point. Each participant completed the PSST scale (to determine PMS severity), HADS scale (for depression and anxiety), and quality of life SF12. RESULTS: The number of people with moderate/severe PMS decreased in LIV3 and LI4 acupressure groups by the second and third cycles compared with the placebo group (p<0.04). Moreover, depression and anxiety scores significantly decreased in the LIV3 and LI4 groups by the second and third cycles compared with the placebo group (p<0.05).Analyzing the score of SF12 fields in the second and third cycles showed a significant difference in all dimensions between the intervention and placebo groups. There was no significant difference between LIV3 and LI4 acupressure groups in decrease of PMS symptoms, anxiety and depression and improving SF12scores (p<0.05). CONCLUSION: Performing the simple acupressure protocol at LIV3 and LI4 is an effective method to decrease the severity of PMS symptoms, anxiety and depression, and to improve the QOL. Pressure at LIV3 and LI4 appears to be equally effective.

Facilitating and inhibiting factors related to treatment adherence in women with polycystic ovary syndrome: A qualitative study.

BACKGROUND: Adherence issues in polycystic ovary syndrome (PCOS) patients have not been examined thoroughly. Patients report prolonged periods of treatment and side effects of the drug as the most common reason for withdrawal from treatment. To improve the effective management of PCOS patients, it is fundamental to understand facilitating and inhibiting factors to treatment adherence. OBJECTIVE: To explore facilitating/inhibiting factors related to treatment adherence among PCOS patients. MATERIALS AND METHODS: This was a qualitative study with a purposive sample of women with confirmed diagnosis of PCOS. The data were collected via 20 in-depth semi-structured interviews with women aged between 21-34 yr. A qualitative content analysis was used to analyze the data. RESULTS: Five themes were identified which described different types of facilitating/ inhibiting factors to treatment adherence. Inhibiting factors included financial issues, patient-related, disease-related, and health care provider-related factors; while social factors were found to be both facilitating and inhibiting. CONCLUSION: The findings suggest that successful adherence to PCOS treatment is highly dependent on patients recognizing and adapting to financial, social, and health care related inhibiting factors. It is also crucial for clinicians and policy makers to recognize these key inhibiting factors in order to improve treatment outcomes.

Association Between Serum Estradiol Level on the Day of hCG Administration and IVF-ICSI Outcome.

BACKGROUND: Controlled ovarian hyperstimulation (COH) for in vitro fertilization (IVF) is essential in improving the pregnancy rate, but supraphysiologic levels of estradiol (E2), which are attained during COH and which affect the outcome of IVF, have remained unclear. The aim of this study was to evaluate the association of E2 levels on the day of hCG with embryo quality and pregnancy rates in long protocol in IVF. MATERIALS AND METHODS: We retrospectively reviewed 128 IVF cycles. All the patients were stimulated with long protocol. The patients were categorized into three groups according to the serum E2 levels on hCG administration day (group 1; <1500 pg/ml, group 2; 1500-3500 pg/ml, group 3; >3500 pg/ml). RESULTS: Of the 128 cycles, 23 (18 %) cycles resulted in pregnancy. There were no statistically significant differences between mean age, duration of infertility, BMI and FSH on cycle day 3 in three groups. The number of the retrieved oocytes, the number of obtained embryos, the number of transferred embryos, and pregnancy rates were gradually increased from group 1 to 3 as estradiol levels increased, and these values were statistically significant (P < 0.05). In addition, the correlation between age and IVF outcome was found. Mean age in patients with positive pregnancy test was lower than that in patients with negative pregnancy test, and this difference was statistically significant. CONCLUSION: This study shows that there is a positive association between estradiol level on hCG administration day and pregnancy rates in IVF cycles.

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.