Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With Human Menopausal Gonadotropin (HMG) in Polycystic Ovary Syndrome
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Endocrine System Diseases Gonadal Disorders |
Drug: low dose human chorionic gonadotropin Drug: Clomiphen citrate plus HMG |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]
- Pregnancy rate [ Time Frame: Within 20 months after recruiting ] [ Designated as safety issue: No ]
- The total dose of ovarian stimulation drugs [ Time Frame: Within 20 months after recruiting ] [ Designated as safety issue: No ]
- The number of embryos available for transfer [ Time Frame: Within 20 months after recruiting ] [ Designated as safety issue: No ]
- The embryo implantation rate and The live birth rate [ Time Frame: Within 20 months after recruiting ] [ Designated as safety issue: No ]
| Enrollment: | 10 |
| Study Start Date: | August 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 30 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Hamid Gourabi, Chief, Royan institute |
| ClinicalTrials.gov Identifier: | NCT00947713 History of Changes |
| Other Study ID Numbers: | Royan-Emb-002 |
| Study First Received: | July 25, 2009 |
| Last Updated: | July 14, 2011 |
| Health Authority: | Iran: Ministry of Health |
Keywords provided by Royan Institute:
|
Human chorionic gonadotropin Clomiphene citrate chronic anovulation Polycystic Ovary Syndrome Follicolugenesis |
Additional relevant MeSH terms:
|
Anovulation Endocrine System Diseases Gonadal Disorders Polycystic Ovary Syndrome Ovarian Diseases Adnexal Diseases Genital Diseases, Female Ovarian Cysts Cysts Neoplasms Chorionic Gonadotropin Clomiphene Menotropins Citric Acid Reproductive Control Agents |
Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Anticoagulants Hematologic Agents Chelating Agents Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Fertility Agents, Female Fertility Agents Selective Estrogen Receptor Modulators |
ClinicalTrials.gov processed this record on May 19, 2013