Combined Metformin and Clomiphene Citrate (CC) or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome (PCOS)
|ClinicalTrials.gov Identifier: NCT00969631|
Recruitment Status : Completed
First Posted : September 1, 2009
Last Update Posted : September 1, 2009
|Condition or disease||Intervention/treatment|
|Polycystic Ovary Syndrome||Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt), CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt),Cairo, Egypt) Procedure: Laparoscopic ovarian diathermy (LOD)|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||282 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combined Metformin and Clomiphene Citrate Versus Laparoscopic Ovarian Diathermy for Ovulation Induction in Clomiphene-resistant Women With Polycystic Ovary Syndrome|
|Study Start Date :||September 2005|
|Primary Completion Date :||February 2009|
|Study Completion Date :||February 2009|
Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt), CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt),Cairo, Egypt)
metformin HCl 1500 daily for 6-8 weeks then 100 mg CC for 5 days starting from day 3 of menstruation up to 6 cycles.
|Active Comparator: Laparoscopic ovarian diathermy (LOD)||
Procedure: Laparoscopic ovarian diathermy (LOD)
Three-puncture technique. Each ovary was cauterized at four points, each for 4 seconds at 40 W for a depth of 4 mm with a mixed current, using an monopolar electrosurgical needle.
- occurrence of ovulation and midcycle endometrial thickness (mm).
- occurrence of pregnancy, miscarriage, multiple pregnancy and live birth rates.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969631
|Mansoura University Hospitals, OB/GYN department|
|Mansoura, Dakahlia Governorate, Egypt|
|Principal Investigator:||Hatem Abu Hashim, MD. MRCOG||Mansoura University Hospitals|
|Study Director:||Naser El Lakany, MD||Mansoura University Hospitals|
|Study Chair:||Lotfi Sherief, MD||Mansoura University Hospitals|