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IRCT20110509006420N18 IRCT 2018-08-20 Yazd University of Medical Sciences progestin primed ovarian stimulation protocol in the polycystic ovarian syndrome progestin primed ovarian stimulation protocol in patients with the polycystic ovarian syndrome in assisted reproductive technology cycles 2018-05-22 anticipated 100 Complete https://irct.ir/trial/32950 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done by sealed envelops. 2 Female infertility, unspecified. Intervention 1: Intervention group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously and 20 mg dydrogesterone (Duphaston) orally. when dominant follicle reaches to 17 mm,final triggering will be done by HCG (Pregnyl - Germany) intramuscular and .2cc decapeptide( Ferring, Germany) Subcutaneously and 36 hours later oocytes pick up will be done.48 latter all embryo will be freeze in cleavage stage and frozen embryo transfer will be done 2 months latter after preparation of endometer by estrogen and progesterone. Intervention 2: Control group: Antagonist group: since second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously When dominant follicle reached to 12-13 mm, cetrotide (Merck- Serono Germany).25 mg will be injected daily subcutaneously. when dominant follicle reaches to 17 mm, final triggering will be done by HCG (Pregnyle - Germany) intramuscular and .2cc decapeptide( Ferring, Germany) Subcutaneously and 36 hours later oocytes pick up will be done.48 latter all embryo will be freeze in cleavage stage and frozen embryo transfer will be done 2 months later after preparation of endometer by estrogen and progestrone. AbstractBackground: In vitro fertilization is an important therapy for women with the polycystic ovarian syndrome (PCOS). The use of new ways of improving clinical results is yet required. Objective: This study was aimed to investigate the efficacy of progesterone primed ovarian stimulation (PPOS) and compare with conventional antagonist protocol in PCOS.Materials and Methods:A total of 120 PCOS women who were candidates for assisted reproductive technology treatment were enrolled in this RCT and were placed into two groups, randomly (n = 60/each). The PPOS group received 20 mg/day Dydrogesterone orally since the second day of the cycle and the control group received antagonist protocol. The pregnancy outcomes including the chemical and clinical pregnancy, the miscarriage rate, and the percent of gestational sacs/transferred embryos were compared in two groups.Results:Number of MII oocyte, maturity rate, Number of 2 pronuclei (2PN) and serum estradiol levels on trigger day were statistically lower in PPOS group (p = 0.019, p =0.035, p = 0.032, p = 0.030), respectively. Serum LH level on trigger day in PPOSgroup was higher than antagonist group (p = 0.005). Although there wasn’t severe ovarian hyperstimulation syndrome in any participants, mild and moderate ovarian hyperstimulation syndrome was less in PPOS group (p = 0.001). Also, the chemical and clinical pregnancy rates were higher in the antagonist group, although it was not statistically significant (p = 0.136, p = 0.093 respectively).Conclusion: Our study demonstrates that PPOS does not improve the chemical and clinical pregnancy rate of infertile women with PCOS. No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the privacy of patients
public Maryam Eftekhar
Bouali
Yazd Iran (Islamic Republic of) 8916877391 +98 35 3824 7085 eftekharmaryam@yahoo.com Yazd University of Medical Sciences scientific Maryam Eftekhar
Bouali
Yazd Iran (Islamic Republic of) 8916877391 +98 35 3824 7085 eftekharmaryam@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) infertile PCOS patients which are candidate for ART 18 years 40 years Female women older than 40 years old History of endocrine disorder Severe endometriosis Azoospermia N97.9 Female infertility, unspecified Treatment - Drugs Treatment - Drugs Intervention group: since the second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously and 20 mg dydrogesterone (Duphaston) orally. when dominant follicle reaches to 17 mm,final triggering will be done by HCG (Pregnyl - Germany) intramuscular and .2cc decapeptide( Ferring, Germany) Subcutaneously and 36 hours later oocytes pick up will be done.48 latter all embryo will be freeze in cleavage stage and frozen embryo transfer will be done 2 months latter after preparation of endometer by estrogen and progesterone. Control group: Antagonist group: since second day of the cycle all patients Will receive 150 unit of cinal f(cinagen-Iran) Subcutaneously When dominant follicle reached to 12-13 mm, cetrotide (Merck- Serono Germany).25 mg will be injected daily subcutaneously. when dominant follicle reaches to 17 mm, final triggering will be done by HCG (Pregnyle - Germany) intramuscular and .2cc decapeptide( Ferring, Germany) Subcutaneously and 36 hours later oocytes pick up will be done.48 latter all embryo will be freeze in cleavage stage and frozen embryo transfer will be done 2 months later after preparation of endometer by estrogen and progestrone Chemical pregnancy. Timepoint: Two weeks after embryo transfer. Method of measurement: Serum BhCG. Clinical pregnancy. Timepoint: Two weeks after positive BhCG. Method of measurement: sonography. Miscarriage rate. Timepoint: Loss of pregnancy before 20 gestational week. Method of measurement: Absence of fetal heart activity in ultra sound sonography. Yazd University of Medical Sciences Approved 2018-05-20 Ethics committee of Infertility Research Center, Shahid Sadoughi University of Medical Sciences, Yaz Bouali Yazd Yazd Iran (Islamic Republic of)