Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With Human Menopausal Gonadotropin (HMG) in Polycystic Ovary Syndrome
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|ClinicalTrials.gov Identifier: NCT00947713|
Recruitment Status : Completed
First Posted : July 28, 2009
Last Update Posted : July 15, 2011
|Condition or disease||Intervention/treatment||Phase|
|Endocrine System Diseases Gonadal Disorders||Drug: low dose human chorionic gonadotropin Drug: Clomiphen citrate plus HMG||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With HMG in PCOs Patients With Previous Clomiphene Citrate (CC)-Resistant Anovulation|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||August 2010|
|Actual Study Completion Date :||December 2010|
|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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|