Comparison of Micro-dose Human Chorionic Gonadotropin (hCG) With Human Menopausal Gonadotropin (HMG) in Polycystic Ovary Syndrome
1 other identifier
interventional
10
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2009
CompletedFirst Posted
Study publicly available on registry
July 28, 2009
CompletedStudy Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedJuly 15, 2011
April 1, 2010
1 year
July 25, 2009
July 14, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Multiple pregnancy rates, OHSS rate
Within 20 months after recruiting
Secondary Outcomes (4)
Pregnancy rate
Within 20 months after recruiting
The total dose of ovarian stimulation drugs
Within 20 months after recruiting
The number of embryos available for transfer
Within 20 months after recruiting
The embryo implantation rate and The live birth rate
Within 20 months after recruiting
Study Arms (2)
Low dose hCG group
EXPERIMENTALClomiphen citrate plus HMG
ACTIVE COMPARATORInterventions
patients will receive low dose human chorionic gonadotropin (HCG) in combination with clomiphen citrate
patients will receive Clomiphen Citrate plus HMG
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Royan Institutelead
Study Sites (1)
Royan institute, Reproductive Medicine Research Centre, ACECR
Tehran, Tehran Province, Iran
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mahnaz Ashrafi
Royan institute, Reproductive Medicine Research Centre, ACECR
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
July 25, 2009
First Posted
July 28, 2009
Study Start
August 1, 2009
Primary Completion
August 1, 2010
Study Completion
December 1, 2010
Last Updated
July 15, 2011
Record last verified: 2010-04