A supportive randomized clinical trial on Iranian infertile women with the history of infertility treatments dropout following unsuccessful ART cycle/s: A study protocol.

Introduction: Due to high dropout rate of infertility treatments and lack of any intervention for motivating infertile couples to continue treatments, the present study will be conducted with the aim of designing, implementing and determining the effectiveness of the proposed intervention in order to continue infertility treatments. Methods: & Analysis: We will conduct this study in two stages; a review of literature and past studies will be done to identify interventions that have been performed for infertile couples, and then an appropriate intervention with the aim of continuing infertility treatments for infertile women will be designed. After that a Delphi study will be designed in accordance with collected information of previous stages and will be approved by experts. In the second stage we will implement designed intervention of a randomized clinical trial on two groups of infertile women (control and intervention) with the history of infertility treatment dropout following unsuccessful cycle. We will use descriptive statistic in first and second stage. In second stage Chi square test and independent samples T test will be used to compare variables between groups and variables in study questionnaires before and after the intervention between two groups of study. Discussion: The present study will be the first study to be performed as a clinical trial on infertile women who have discontinued the treatments, with the aim of continuing treatments. Thereupon, it seems that the results of this study will be the basis for studies around the world to prevent premature cessation of infertility treatments.

Quality of life in terminally ill cancer patients: what is the role of using complementary and alternative medicines?

BACKGROUND AND PURPOSE: Cancer is the world's second greatest cause of mortality and a leading cause of death in both developed and developing countries. Patients employ a number of complementary and alternative medicine (CAM) methods to deal with the problems and difficulties of cancer, which can have an impact on their quality of life (QOL). The aim of the present study was to assess the correlation between QOL and the use of different CAM methods in terminally ill cancer patients. METHODS: This was a cross-sectional study. In southern Iran, 238 individuals with advanced cancer were studied in oncology centers and doctors' offices. During the months of January to August 2021, patients were selected using convenience sampling. A demographic information questionnaire, the EORTC core quality of life questionnaire, and the CAM questionnaire were used to collect data. RESULTS: The results showed that terminally ill cancer patients had a good quality of life. Last year, 85.7% of participants used at least one kind of CAM. Furthermore, 45.4% of participants used only one form of CAM, 30.3% used two types of CAM, 6.7% used three types of CAM, and 3.4% used four to five types of CAM. When all CAM users were compared to non-CAM users, CAM users had significantly higher social QOL and overall quality of life. Two subscales of QOL symptoms and function were correlated with cancer history, income, and use of CAMs, and the scores of QOL symptoms and function were greater in CAM users compared to non-CAM users. Among all the study variables, only the usage of CAM was correlated to overall QOL among terminally ill cancer patients. CONCLUSION: The current study found that using CAM could affect different aspects of QOL in terminally ill cancer patients. As a result, it is feasible that using CAM could help these people enhance their health and QOL.

Psychosomatic Symptoms in Terminally Ill Cancer Patients and Its Relation With Using Complementary and Alternative Medicines: A Cross-Sectional Study in Southeast Iran.

Background: Cancer patients face various problems and complications, which they address through various complementary and alternative medicines (CAM). The aim of this study was to investigate the relationship between CAM and psychosomatic symptoms in terminally ill cancer patients. Methods: This cross-sectional study was performed on 221 terminally ill cancer patients (based on metastatic stage and according to the physicin diagnosis) in southeastern Iran. Convenience sampling was used to select terminally ill cancer patients. Using questionnaires like the demographic and clinical information questionnaire, Edmonton Symptom Assessment Scale (ESAS), Hospital Anxiety and Depression Scale (HADS), CAM questionnaire and satisfaction with the use of CAM, the researcher was able to compile a comprehensive picture of the population. Results: The mean age of the participants was 51.66 ± 13.34 years. The majority of the samples were female, married, educated, and unemployed. The mean score for the physical symptoms of the participants according to ESAS was 22.25 ± 17.57 which was less than the midpoint of the scale (the possible score of ESAS was 0-100). Only 2.7% (n = 6) and 0.9% (n = 2) of the participants had mild and moderate anxiety, respectively, and the other participants' anxiety levels were normal. Only 7.7% (n = 17) and 4.1% (n = 9) of the participants had mild and moderate depression, respectively, and the other participants' depression levels were normal. Last year, 87.3% of the participants used at least one type of CAM. Aside from prayer, 42.1% of the participants used at least one type of CAM in the last year. Prayer was used by 83.7% of the participants, medicinal plants by 35.8%, massage by 9.5%, dietary supplements by 3.6%, wet cupping by 3.2%, relaxation and meditation by 2.7%, dry cupping by 2.4%, and acupuncture by 0.5%. The common reason for using CAM was to reduce the stress and anxiety caused by cancer and to treat it. There were no significant differences in physical and psychological symptoms between the CAM-users and non-CAM users. Conclusion: Patients with cancer have a relatively low level of psychosomatic symptoms, and the primary reason for using CAM was to relieve stress and anxiety associated with cancer and treat it. However, psychosomatic symptoms were the same for CAM and non-CAM users. Because so many people with cancer use CAM, future studies should look into why and how CAM is used.

A systematic review and meta-analysis on dropout of infertility treatments and related reasons/factors.

Dropout of infertility treatments is a common phenomenon and many patients avoid continuing infertility treatments. Determining the total rate of treatment dropout, and related factors was the objective of the present systematic review and meta-analysis study. We performed an electronic literature search in Web of Science, Scopus, Embase, Cinhal, ProQuest and Medline databases and a manual search in Google scholar by using a set of Standard keywords. We included descriptive studies in English or Persian, from August 2000 to 2019. Finally, we extracted data of 25 papers for systematic review and 11 papers for meta-analysis. Data analysed by RevMan software. The results of the meta-analysis analysed by the random-effects model and studies heterogeneity analysed using the I2 calculation index. We tried to control high heterogeneity (because of the small amounts of p value and chi-square and large amount of I2) with statistical methods such as subgroup analysis and using random-effects model. The results showed that factors related to treatment, psychological and demographic/personal factors are the most common factors for dropout. It seems that educational and supportive programs on psychological, financial, therapeutic, demographic and personal factors can play an important role in reducing the incidence of infertility treatment's drop out before completing the course of treatment.

Tehran environmental and neurodevelopmental disorders (TEND) cohort study: Phase I, feasibility assessment.

PURPOSE: To advance knowledge about childhood neurodevelopmental disorders and study their environmental determinants, we conducted a study in Tehran, Iran to assess the feasibility of prospective birth cohort study. METHODS: We evaluated participation of pregnant women, feasibility of sampling biological material, and health care services availability in Tehran in four steps: (1) first trimester of pregnancy; (2) third trimester of pregnancy; (3) at delivery; and (4) two to three months after delivery. We collected related data through questionnaires, also various biological samples were obtained from mothers (blood, urine, milk and nails-hands and feet) and newborns (umbilical cord blood, meconium, and urine samples) from February 2016 to October 2017. RESULTS: overall 838 eligible pregnant women were approached. The participation rate was 206(25%) in our study and about 185(90%) of subjects were recruited in hospitals. Out of 206 participants in the first trimester, blood, urine, hand nail, and foot nail samples were collected from 206(100%),193(93%), 205(99%), and 205(99%), respectively. These values dropped to 65(54%), 83(69%), 84(70%), and 84(70%) for the remaining participants 120(58%) in the third trimester, respectively. Also, we gathered milk samples from 125(60%) of mothers at two to three months after delivery. CONCLUSION: Our findings suggest that hospitals were better places for recruitment of subjects in a birth cohort in Tehran. We further concluded that birth cohort study recruitment can be improved by choosing appropriate gestational ages. Obtaining the newborn's urine, meconium, and umbilical cord blood were challenging procedures and require good collaboration between hospital staff and researchers.

Comparison of Gene Expression Profiles in Human Germinal Vesicle Before and After Cytoplasmic Transfer From Mature Oocytes in Iranian Infertile Couples.

OBJECTIVE: To evaluate the effect of cytoplasm transfer from mature oocytes to germinal vesicle(GV)s on promoting the maturation of cytoplasm of GV at the mRNA level. MATERIALS AND METHODS: Sixty six in vitro fertilization (IVF) operations between June 2012 and November 2013 were included in this study. Totally 120 GVs were obtained. Normal GVs were categorized into 3 groups (n = 40) randomly: the first comprised oocytes that did not receive the cytoplasm of mature oocytes; the second group comprised oocytes that did not receive the cytoplasm of mature oocytes but were incubated for 24 h; and the third group comprised oocytes that received 10-15% the cytoplasm of mature oocytes and were then incubated for 24 h. Each group was separately analyzed by quantitative polymerase chain reaction (qPCR) and the expression levels of selected genes were assessed. RESULTS: The expression levels of genes involved in the cytoplasmic maturity, and energy-producing mitochondria were significantly higher in the pooled oocytes of 2(nd) control group than those of the 1(st) control and intervention groups (p < 0.001). The genes involved in the meiosis, spindle check point, DNA repairing and cell cycle checkpoint did not have any expression in the 1(st) and intervention groups; however, these genes were expressed in the 2(nd) group, significantly. In the 2(nd) group, the highest expression level was observed for genes involved in the DNA repairing and cell cycle checkpoint. In the intervention group, none of the genes were expressed except for energy-producing mitochondria gene; even in this case, the expression level of this gene in this group of oocytes was significantly lower than that in other groups (p < 0.001). After 24 h meiosis assumption was significantly higher in the third group than in the second group (95% vs. 68%, p < 0.001). CONCLUSION: The cytoplasm transfer technique is not effective in cytoplasmic maturity of the recipient GV oocytes. In contrast, 24-hr in-vitro culture is associated with increased expression of studied genes in GVs.

A randomized controlled trial of gonadotropin-releasing hormone agonist versus gonadotropin-releasing hormone antagonist in Iranian infertile couples: oocyte gene expression.

BACKGROUND: The main objective of the present work was to compare the effects of the gonadotropin-releasing hormone agonist (GnRH-a) and GnRH antagonist (GnRH-ant) on the gene expression profiles of oocytes obtained from Iranian infertile couples undergoing in vitro fertilization (IVF). METHODS: Fifty infertile couples who underwent IVF between June 2012 and November 2013 at the Infertility Center of Tehran Women General Hospital, Tehran University of Medical Sciences, were included in this study. We included women that had undergone IVF treatment because of male factor, tubal factor, or unexplained infertility. The women randomly underwent controlled ovarian stimulation (COS) with either the GnRH-a (n = 26) or the GnRH-ant (n = 24). We obtained 50 germinal vesicle (GV) oocytes donated by women in each group. After the sampling, pool of 50 GV oocytes for each group was separately analyzed by quantitative polymerase chain reaction (qPCR). RESULT: The expression levels of Adenosine triphosphatase 6 (ATPase 6), Bone morphogenetic protein 15 (BMP15), and Neuronal apoptosis inhibitory protein (NAIP) genes were significantly upregulated in the GnRH-ant group compared to the GnRH-a group, with the fold change of 3.990 (SD ± 1.325), 6.274 (SD ± 1.542), and 2.156 (SD ± 1.443), respectively, (P < 0.001). Growth differentiation factor 9 (GDF9) mRNA did not have any expression in the GnRH-a group; however, GDF9 mRNA was expressed in the GnRH-ant group. Finally, it was found that the genes involved in the DNA repairing and cell cycle checkpoint did not have any expression in either group. CONCLUSION: The present study showed, for the first time, the expression levels of genes involved in the cytoplasmic maturity (BMP15, GDF9), adenosine triphosphate production (ATPase 6), and antiapoptotic process (NAIP), in human GV oocytes were significantly higher in the GnRH-anta group than in the GnRH-a group in COS. Higher expression level of these genes when GnRH-ant protocol is applied, this protocol seems to be a more appropriate choice for women with poly cystic ovarian syndrome, because it can probably improve the expression of the aforementioned genes. TRIAL REGISTRATION: Current Controlled Trials: IRCT 2014031112307 N3.

A Randomized, Controlled Trial of Levonorgestrel Vs. The Yuzpe Regimen as Emergency Contraception Method among Iranian Women.

BACKGROUND: We aimed to compare acceptability of Levonorgestrel with the Yuzpe regimen among Iranian women based on their side-effects and resulting changes in the amount and pattern of menses. METHODS: Five hundred twenty nine participants aged 15-49 having regular menses and one act of unprotected intercourse within 72 h were included in the double-blind, controlled trial in 2006-2007 and randomly assigned into LNG (n=263) and HD (n=266) groups, receiving Levonorgestrel 0.75 mg given 12 h apart and ethinyl estradiol 100 µg plus 0.5 mg Levonorgestrel 0.5 mg repeated after 12 h, respectively. RESULTS: The participants receiving Levonorgestrel experienced significantly lower side-effects in the case of nausea, vomiting, and dizziness (P<0.05). The changes occurred in the amount and pattern of menses were the same for both groups (P>0.05). No significant difference was observed between the efficiencies of the treatments. CONCLUSION: Significantly lower side-effects of Levonorgestrel can be considered as greater acceptability and translated to higher efficiency.