Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With Human Menopausal Gonadotropin (HMG) in Polycystic Ovary Syndrome
|Endocrine System Diseases Gonadal Disorders||Drug: low dose human chorionic gonadotropin Drug: Clomiphen citrate plus HMG||Phase 1 Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
|Official Title:||Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With HMG in PCOs Patients With Previous Clomiphene Citrate (CC)-Resistant Anovulation|
- Multiple pregnancy rates, OHSS rate [ Time Frame: Within 20 months after recruiting ]
- Pregnancy rate [ Time Frame: Within 20 months after recruiting ]
- The total dose of ovarian stimulation drugs [ Time Frame: Within 20 months after recruiting ]
- The number of embryos available for transfer [ Time Frame: Within 20 months after recruiting ]
- The embryo implantation rate and The live birth rate [ Time Frame: Within 20 months after recruiting ]
|Study Start Date:||August 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
|Experimental: Low dose hCG group||
Drug: low dose human chorionic gonadotropin
patients will receive low dose human chorionic gonadotropin (HCG) in combination with clomiphen citrate
Other Name: human chorionic gonadotropin
|Active Comparator: Clomiphen citrate plus HMG||
Drug: Clomiphen citrate plus HMG
patients will receive Clomiphen Citrate plus HMG
Infertile women with PCOS, who have showed resistance to Clomiphen Citrate (150 mg- 5 days) in a previous IUI treatment cycle at Royan Institute (Infertility and Reproductive Medicine Research Centre) will enroll in this prospective randomized clinical trial study and will randomly be divided into three groups.
The study protocol will be assessed by an independent institutional review board and Royan ethics committee. All subjects will be given the written informed consent.
Control group (CC/hMG) will receive the 100 mg CC on days 3 to 7 of that cycle but will receive 150 mg human menopausal gonadotropin (HMG) during days of 7, 8, and 9. One of experimental Group (group B) will receive a 100 mg dose of CC but will receive a 200 IU Human chorionic gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection daily when the largest follicle is 12 mm or larger mean diameter. Other experimental group (Group C) will receive a 100 mg dose of CC but will receive a 200 IU Human chorionic gonadotropin (hCG; Choriomon; IBSA, Switzerland) intramuscular injection daily From day 9(without attention to follicle size). In both experimental groups HCG administration will be continued until the largest follicle is 18-20 mm.
Ultrasound measurements of follicle number and growth, ovulation, gestational sac, and serum hormonal levels will be recorded and compared between two groups.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00947713
|Iran, Islamic Republic of|
|Royan institute, Reproductive Medicine Research Centre, ACECR|
|Tehran, Iran, Islamic Republic of|
|Principal Investigator:||Mahnaz Ashrafi||Royan institute, Reproductive Medicine Research Centre, ACECR|