Effect of Adding Intravenous Somatostatin to Rectal Indomethacin on Post-Endoscopic Retrograde Cholangiopancreatography (ERCP) Pancreatitis in High-risk Patients: A Double-blind Randomized Placebo-controlled Clinical Trial.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) has an important role in the treatment of pancreaticobiliary disorders. GOALS: Considering the high prevalence and importance of postendoscopic retrograde cholangiopancreatography pancreatitis (PEP) and the controversial findings, we aimed to determine the effect of adding intravenous somatostatin to rectal indomethacin on the incidence of PEP in high-risk patients. STUDY: In this prospective study, 530 patients underwent ERCP during March 2018 and February 2019. Patients were randomized into 2 groups. The intervention group received a bolus injection of 250 µg somatostatin followed by an infusion of 500 µg of somatostatin for 2 hours. In both groups, 100 mg of pre-ERCP suppository indomethacin was administrated. All patients were screened for PEP symptoms and signs for 24 hours after ERCP (Iranian Registry of Clinical Trials code: IRCT20080921001264N11). RESULTS: A total of 376 patients were finally analyzed. PEP was the most common adverse event with 50 (13.2%) episodes, including 21 (5.5%) mild, 23 (6.1%) moderate, and 6 (1.2%) severe. The rate of PEP was 15.2% in the control group and 11.4% in the intervention group ( P =0.666). The incidence of post-ERCP hyperamylasemia was 21.7% in the control group and 18.2% in the intervention group ( P =0.395). No death occurred. CONCLUSIONS: In this study administration of somatostatin plus indomethacin could safely reduce the rate of post-ERCP hyperamylasemia and PEP in the intervention group compared with the control group, but the differences were not significant. Further studies with larger sample sizes are required.

A Comparison of Postpartum Depression in Mothers Conceived by Assisted Reproductive Technology and Those Naturally Conceived.

BACKGROUND: It is thought that mothers who conceive via assisted reproductive technology (ART) may be at greater risk of postpartum depression (PPD) because of the problems and psychological stresses associated with ART treatment. The aim of the present study is to determine the occurrence of PPD among mothers who conceive by ART in comparison with those who naturally conceive. The Edinburgh Postnatal Depression Scale (EPDS) was used to assess PPD. MATERIALS AND METHODS: This historical cohort study investigated 406 mothers with infants aged 3-9 months. Three hundred and eight women with natural pregnancies were selected as the control group from mothers who referred to Tehran healthcare centres for infant vaccinations. The ART group consisted of 98 women who conceived via ART at Royan Institute. Participants completed a general questionnaire that asked about education, occupation, number of children, delivery method, history of infant hospitalization, breastfeeding, mothers' and infants' ages, cause of infertility (ART group), and history of depression. A validated Persian version of the EPDS was used to measure depressive symptoms. RESULTS: The mean EPDS score in mothers who naturally conceived was 8.38 ± 0.35 in comparison with mothers who conceived via ART (7.59 ± 0.63). The proportions of women who reported PPD were 26.0% for the control group and 20.4% for the ART group. There was no statistically significant difference in PPD between the control and ART groups (P=0.26). CONCLUSION: The occurrence of PPD in mothers who conceived via ART was similar to those who conceived naturally.

Satisfaction with Information Provided to Infertile patient Who Undergo Assisted Reproductive Treatment.

BACKGROUND: Potentially modifiable factors, such as the appropriate informing process given to infertile patients, can affect their infertility knowledge and information. This study aims to assess infertility information provided to Iranians who undergo assisted reproductive treatment. MATERIALS AND METHODS: In this cross-sectional study, participants recruited were a convenience sample of all infertile patients who received assisted reproductive treatments from Royan Institute, Tehran, Iran. Inclusion criteria consisted of: patient's first time visit, no previous infertility treatment failures, and referral to the centre between January and March 2015. A 20-item tool designed by researchers measured patient satisfaction with the infertility informing process. This tool included cause of infertility, type of recommended treatment, diagnostic procedures, approximate treatment duration, success rate of the treatment, approximate cost of treatment, and non-therapeutic factors in treatment success. RESULTS: A total of 235 infertile patients were invited to participate in the study, from which 200 (100 men and 100 women) participants completely responded to the questionnaire with a response rate of approximately 85%. The mean age of participants was 30.93 ± 5.56 years. In terms of satisfaction with information provided about the cause of infertility, male responders reported the lowest mean score of 3.59 ± 1.05 compared to female responders (3.82 ± 0.85, P=0.078). Infertile women had a greater mean score of 3.85 ± 0.78 than infertile men (3.58 ± 1.29) in satisfaction with information provided about the type of recommended treatment (P=0.037). There was a statistically significant difference between males (3.26 ± 1.04) and females (3.58 ± 0.93) in satisfaction with approximate treatment duration (P=0.031). CONCLUSION: According to the results, most infertile patients were satisfied with the informing process related to the cause of infertility and recommended therapies. Information about infertility should be provided more systematically to all treated patients by medical staff, especially in terms of success rate of treatment and financial cost of therapy.

Identification of Reproductive Education Needs of Infertile Clients Undergoing Assisted Reproduction Treatment Using Assessments of Their Knowledge and Attitude.

BACKGROUND: In order to empower infertile individuals and provide high quality patient-centered infertility care, it is necessary to recognize and meet infertile individuals' educational needs. This study aims to examine infertility patients' knowledge and subsequently their education needs given their attitudinal approach to infertility education in terms of patients who undergo assisted reproduction treatment. MATERIALS AND METHODS: This descriptive study enrolled 150 subjects by conveni- ence sampling of all patients who received their first assisted reproductive treatment between July and September 2015 at a referral fertility clinic, Royan Institute, Tehran, Iran. We used a questionnaire that measured fertility and infertility information (8 questions) as well as attitude toward education on the causes and treatment of infertility (5 questions). Chi-square, independent sample t test, and one way ANOVA analyses were conducted to examine differences by sex. P<0.05 was considered statistically significant. RESULTS: Total mean knowledge was 3.08 ± 0.99. Clients' responses indicated that the highest mean knowledge scores related to knowledge of factors that affected pregnancy (3.97 ± 1.11) and infertility treatment (3.97 ± 1.16). The lowest mean knowledge scores related to knowledge of the natural reproductive cycle (2.96 ± 1.12) and anatomy of the genital organs (2.94 ± 1.16). Most females (92.1%) and males (83.3%) were of the opinion that infertility education programs should include causes of infertility and types of treatment associated with diagnostic and laboratory procedures. No statistically significant difference existed between male and female participants (P=0.245). CONCLUSION: Most participants in this study expressed awareness of factors that affect pregnancy and infertility treatment. It is imperative to educate and empower infertile individuals who seek reproduction treatment in terms of infertility causes and types of treatment, as well as diagnostic and laboratory procedures to enable them to make informed decisions about their assisted reproductive procedures.

Psychometric Properties of The Persian Version of The Prenatal Attachment Inventory in Pregnant Iranian Women.

BACKGROUND: In 1993, Muller developed the Prenatal Attachment Inventory (PAI) which has been used widely in many studies and translated into several languages. The current study aimed to translate the PAI into Persian, assess the underlying structure of the PAI, and the appropriateness of the one-factor solution proposed by Muller. MATERIALS AND METHODS: In this cross-sectional study, we recruited a total of 322 primi- gravidae in their 27(th) to 34(th) gestational weeks that referred to private and governmental prenatal clinics in Tehran, Iran. All participants completed the Persian versions of the PAI and a demographic questionnaire. Participants were re-tested 2 weeks after the initial test- ing. The following psychometric properties of the PAI were investigated: construct validity by confirmatory factor analysis (CFA), internal consistency reliability with Cronbach's alpha, and test-retest reliability according to the intraclass correlation coefficient (ICC). RESULTS: The CFA results indicated that a single-factor model provided good fit to the data, which confirmed the original model by its developer. The Cronbach's alpha coef- ficient for PAI was 0.856 and the test-retest reliability with ICC was 0.784. Consider- ing the duration between marriage and pregnancy, women with low duration scored significantly higher than women with high duration on PAI (P=0.043). CONCLUSION: The Persian version of the PAI showed that one factor structure was ad- equate and could be used for measuring psychological affectionate attachment between Iranian mothers and their fetuses.

Psychometric properties of the satisfaction with life scale (SWLS) in Iranian infertile women.

BACKGROUND: Infertility is a global public health issue and may adversely affect life satisfaction. One of the most widely instruments used to assess life satisfaction is the Satisfaction with Life Scale (SWLS). OBJECTIVE: The objective of this study was to examine the psychometric properties of the SWLS in Iranian infertile women. MATERIALS AND METHODS: In this descriptive cross-sectional study, a total of 125 infertile women referring to Royan Institute in Tehran were selected by convenience sampling method. The participants were administered the SWLS, the Hospital Anxiety and Depression Scale (HADS), and a demographic questionnaire. The psychometric properties of the SWLS were examined: construct validity using confirmatory factor analysis (CFA), reliability using Cronbach's alpha and convergent validity by examining the relationship with HADS. RESULT: Results of the CFA indicated that a single-factor model provides a good fit to the data (χ(2)/df= 1.58; GFI= 0.975; CFI= 0.995; NFI= 0.985; RMSEA= 0.069 and SRMR= 0.027). The Cronbach's alpha coefficient for SWLS was 0.887. Significant negative correlations were found between SWLS and HADS scores for anxiety (r= -0.410) and depression (r= -0.434), indicating an acceptable convergent validity. CONCLUSION: The SWLS has adequate psychometric properties for assessing life satisfaction in Iranian infertile women.

Development of A Questionnaire to Measure Attitude toward Oocyte Donation.

BACKGROUND: To our knowledge, there is no valid and comprehensive questionnaire that considers attitude toward oocyte donation (OD). Therefore this study has aimed to design and develop a tool entitled attitude toward donation-oocyte (ATOD-O) to measure attitude toward OD. MATERIALS AND METHODS: This methodological, qualitative research was undertaken on 15 infertile cases. In addition, we performed a literature review and search of various databases. Validity of this questionnaire was conducted by knowledgeable experts who determined indices such as relevancy, clarity, and comprehensiveness. Reliability of the questionnaire was assessed based on the opinions of experts and infertile couples referred to Royan Institute. RESULTS: ATOD-O was designed in 52 statements that covered various issues such as the OD process, donor and recipient characteristics, as well as family, emotional, psychological, legal, religious, and socio-economic dimensions. Results were scored as five points: 1 (strongly disagree), 2 (disagree), 3 (somewhat), 4 (agree), and 5 (strongly agree). The overall relevancy of the questionnaire was 97% and clarity was 96%. Overall comprehensiveness was 100%. CONCLUSION: The findings from this preliminary validation study have indicated that ATOD-O is a valid measure for measuring and assessing attitude toward donated oocytes. This questionnaire can be used in studies regarding different groups of a society.

Comparing the efficacy of urinary and recombinant hCG on oocyte/follicle ratio to trigger ovulation in women undergoing intracytoplasmic sperm injection cycles: a randomized controlled trial.

PURPOSE: To compare the number of oocytes per follicles in ovulation induction with 10,000 IU urinary hCG (uhCG) and two different doses of recombinant hCG (rhCG) in women undergoing intracytoplasmic sperm injection (ICSI) cycles. METHODS: This study was a prospective, randomized controlled trial which was performed on 180 primary infertile women undergoing ICSI cycles. All eligible patients underwent a standard GnRH-a long protocol. When at least two follicles reached a diameter of 18 mm, all patients were randomized to receive 10,000 IU urinary hCG or 250 µg recombinant hCG or 500 µg recombinant hCG for ovulation induction. Primary outcome measure included the number of oocytes retrieved per aspirated follicles. Secondary outcome measures were the number of oocytes retrieved, the number of mature oocytes, the number and quality of generated embryos, fertilization rate, implantation rate, chemical and clinical pregnancy rates and OHSS occurrence rate. RESULTS: The mean number of retrieved oocytes per follicles were 71.82 ± 15.09, 69.84 ± 17.44 and 77.16 ± 17.61 in 10,000 IU uhCG, 250 µg rhCG and 500 µg rhCG, respectively which was significantly higher with 500 µg rhCG than the lower dose(P = .04). Other cycles and clinical outcomes were comparable between groups. CONCLUSION: Recombinant hCG shows equivalent efficacy to urinary hCG in terms of the number of oocytes per aspirated follicles in selected patients undergoing ICSI; however, 500 µg rhCG seems to be more advantageous than the lower dose in this indication. Larger randomized trials are needed to generalize this strategy.

Half-dose, long-acting gonadotropin-releasing hormone agonist (Diphereline) is comparable with daily injections of short-acting gonadotropin-releasing hormone agonist (Suprefact) in IVF/ICSI cycles.

INTRODUCTION: The aim of the study was to compare the efficacy of half-dose, long-acting GnRH analogue (Diphereline) with Suprefact in IVF/ICSI (in vitro fertilization/intracytoplasmic sperm injection) cycles. MATERIAL AND METHODS: In this randomized clinical trial performed in Royan Institute, 126 infertile women who were first time candidates for IVF/ICSI were enrolled. Patients were randomly divided into two groups by using a random number table. In one group, 62 patients received a single half dose, 1.87 mg Diphereline, in mid-luteal phase. In the other group, 64 cases were treated with buserelin from the previous mid-luteal phase. P value less than 0.05 was considered significant. RESULTS: The mean age of patients in the Diphereline and Suprefact groups was 27.9 ±3.6 and 29.6 ±3.5 years, respectively (p = 0.01). In the Diphereline group, the mean number of used gonadotropins was 25.6 ±12.1 ampoules, while in the second group it was 25.9 ±8.5 ampoules. Numbers of retrieved and MII oocytes were significantly higher in the Diphereline group (12.1 ±6.3 and 9.6 ±5.5) in comparison to the Suprefact group (9.4 ±6.4 and 7.2 ±5.1). Although the number of developed embryos in the Diphereline group was statistically higher than in the Suprefact group (6.1 ±3.9 vs. 4.7 ±3.4, p = 0.04) there was no significant difference in pregnancy rate (37.1%, 95% CI [26.16-49.54] vs. 37.5%, 95% CI [26.67-49.75]). CONCLUSIONS: A half-dose, long-acting GnRH agonist can be successfully used in ovarian stimulation and produces a higher number of MII oocytes and embryos. The pregnancy rates with this method are acceptable.

Calciotropic hormones, insulin resistance, and the polycystic ovary syndrome.

OBJECTIVE: To investigate whether abnormalities in serum concentrations of 1,25-dihydroxyvitamin D [1,25(OH)(2)D], 25-hydroxyvitamin D [25(OH)D], parathyroid hormone (PTH), calcium, and phosphorus were associated with risk of polycystic ovary syndrome (PCOS) and obesity. The possible correlations of the calciotropic hormones with insulin resistance were also examined. DESIGN: Case-control study. SETTING: Department of Genetics, Royan Institute. PATIENT(S): Eighty-five women with PCOS and 115 control women were recruited. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Serum levels of glucose, insulin, total calcium, phosphorus, PTH, 25(OH)D, and 1,25(OH)(2)D were measured in all 200 subjects. RESULT(S): The presence of PCOS had age- and body mass index (BMI)-independent positive effects on serum phosphorus, PTH, 25(OH)D, and insulin concentrations as well as on insulin resistance. Furthermore, overweight/obese (BMI > or =25 kg/m(2)) women with PCOS had significantly decreased levels of 1,25(OH)(2)D and glucose compared with normal-weight (BMI <25 kg/m(2)) women with PCOS. In women with PCOS, phosphorus was correlated negatively with insulin and insulin resistance and positively with 1,25(OH)(2) D. In addition, in normal-weight patients, PTH correlated positively with insulin and insulin resistance. CONCLUSION(S): It is possible that elevated levels of phosphorus and PTH in women with PCOS, at least in part, through their effects on insulin levels and insulin resistance, are involved in pathogenesis of the syndrome.