A Phase 1/2 interventional study of low dose human chorionic gonadotropin and Clomiphen citrate plus HMG in Endocrine System Diseases and Gonadal Disorders, sponsored by Royan Institute. Completed at 1 site in Iran, Islamic Republic of. Open to female participants aged 18 Years to 30 Years. Per ClinicalTrials.gov, last updated 2011-07-15.
Sponsored by Royan Institute · Phase 1/2, Interventional, and Prevention
The purpose of this study is to compare the effectiveness of low dose human chorionic gonadotropin (HCG) in combination with clomiphen citrate to induce ovulation and its endocrine response in patients who had previously failed to ovulate on clomiphen citrate alone. The investigators will also compare the effectiveness and endocrine response of this approach with the regimen of adding HMG to clomiphen citrate.
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 175 are open to participants now.
This study's enrollment of 10 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →Royan Institute is the lead sponsor of 92 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Drug: low dose human chorionic gonadotropin
Drug: Clomiphen citrate plus HMG
patients will receive low dose human chorionic gonadotropin (HCG) in combination with clomiphen citrate
Also known as: human chorionic gonadotropin
patients will receive Clomiphen Citrate plus HMG
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
This study is completed, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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Royan Institute