Combined Metformin and Clomiphene Citrate (CC) or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome (PCOS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00969631|
Recruitment Status : Completed
First Posted : September 1, 2009
Last Update Posted : September 1, 2009
|Condition or disease||Intervention/treatment||Phase|
|Polycystic Ovary Syndrome||Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt), CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt),Cairo, Egypt) Procedure: Laparoscopic ovarian diathermy (LOD)||Not Applicable|
|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|
|Actual Primary Completion Date :||February 2009|
|Actual 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.
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): 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|