Endocrine System Diseases Clinical Trial
Official title:
Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With HMG in PCOs Patients With Previous Clomiphene Citrate (CC)-Resistant Anovulation
Verified date | April 2010 |
Source | Royan Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | December 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 30 Years |
Eligibility |
Inclusion Criteria: - Women with PCOS diagnosed by the Rotterdam criteria - Previously documented dominant follicle or follicles (R12 mm mean diameter) on transvaginal Ultrasound follicular monitoring while receiving CC at the 150-mg dose in our clinic but have failed to ovulate; - Primary infertility - Documented normal uterine cavity and patent tubes by either hysterosalpingogram or laparoscopy and hysteroscopy; - Male partner had to have a normal semen analysis by World Health Organization criteria. Exclusion Criteria: - previous history of IVF or ICSI treatments. - History of hormonal treatment within recent three month (Except OCP, progesterone). - History of ovarian cutter or Ovarian drilling. - BMI higher than 30. - The presence of ovarian cyst (more than 30 mm) during third cycle ultrasound. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Royan institute, Reproductive Medicine Research Centre, ACECR | Tehran |
Lead Sponsor | Collaborator |
---|---|
Royan Institute |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Multiple pregnancy rates, OHSS rate | Within 20 months after recruiting | Yes | |
Secondary | Pregnancy rate | Within 20 months after recruiting | No | |
Secondary | The total dose of ovarian stimulation drugs | Within 20 months after recruiting | No | |
Secondary | The number of embryos available for transfer | Within 20 months after recruiting | No | |
Secondary | The embryo implantation rate and The live birth rate | Within 20 months after recruiting | No |
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