Back to resultsCombined Metformin and Clomiphene Citrate (CC) or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome (PCOS)
Primary Purpose
Polycystic Ovary Syndrome
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
metformin HCl (Cidophage®; CID,Cairo, Egypt), CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt),Cairo, Egypt)
Laparoscopic ovarian diathermy (LOD)
Sponsored by
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovary syndrome, clomiphene resistance, metformin, laparoscopic ovarian diathermy
Eligibility Criteria
Inclusion Criteria:
- CC resistant PCOS
Exclusion Criteria:
- Congenital adrenal hyperplasia
- Cushing syndrome
- Androgen secreting tumors
Sites / Locations
- Mansoura University Hospitals, OB/GYN department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Metformin-CC
Laparoscopic ovarian diathermy (LOD)
Arm Description
Outcomes
Primary Outcome Measures
occurrence of ovulation and midcycle endometrial thickness (mm).
Secondary Outcome Measures
occurrence of pregnancy, miscarriage, multiple pregnancy and live birth rates.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00969631
Brief Title
Combined Metformin and Clomiphene Citrate (CC) or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome (PCOS)
Official Title
Combined Metformin and Clomiphene Citrate Versus Laparoscopic Ovarian Diathermy for Ovulation Induction in Clomiphene-resistant Women With Polycystic Ovary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare and determine the efficacy of combined metformin and Clomiphene citrate administration to that of laparoscopic ovarian diathermy (LOD) in infertile women with Polycystic ovary syndrome (PCOS) not responding to treatment with Clomiphene alone.
Detailed Description
All patients in the combined metformin-CC group received metformin HCl (Cidophage®;Chemical Industries Development,Cairo, Egypt), 500 mg thrice daily for 6-8 weeks. Then after the end of this period, they received 100 mg CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt) for 5 days starting from day 3 of menstruation (increased by 50 mg in the next cycle in case of anovulation ). Patients continued treatment for up to six cycles. Metformin was stopped only when pregnancy was documented. All patients in the control group underwent laparoscopic ovarian diathermy, then followed up for 6 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Polycystic ovary syndrome, clomiphene resistance, metformin, laparoscopic ovarian diathermy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
282 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Metformin-CC
Arm Type
Experimental
Arm Title
Laparoscopic ovarian diathermy (LOD)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
metformin HCl (Cidophage®; CID,Cairo, Egypt), CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt),Cairo, Egypt)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic ovarian diathermy (LOD)
Intervention Description
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.
Primary Outcome Measure Information:
Title
occurrence of ovulation and midcycle endometrial thickness (mm).
Secondary Outcome Measure Information:
Title
occurrence of pregnancy, miscarriage, multiple pregnancy and live birth rates.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
36 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
CC resistant PCOS
Exclusion Criteria:
Congenital adrenal hyperplasia
Cushing syndrome
Androgen secreting tumors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatem Abu Hashim, MD. MRCOG
Organizational Affiliation
Mansoura University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Naser El Lakany, MD
Organizational Affiliation
Mansoura University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lotfi Sherief, MD
Organizational Affiliation
Mansoura University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura University Hospitals, OB/GYN department
City
Mansoura
State/Province
Dakahlia Governorate
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
17007847
Citation
Siebert TI, Kruger TF, Steyn DW, Nosarka S. Is the addition of metformin efficacious in the treatment of clomiphene citrate-resistant patients with polycystic ovary syndrome? A structured literature review. Fertil Steril. 2006 Nov;86(5):1432-7. doi: 10.1016/j.fertnstert.2006.06.014. Epub 2006 Sep 27.
Results Reference
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PubMed Identifier
14739186
Citation
Bayram N, van Wely M, Kaaijk EM, Bossuyt PM, van der Veen F. Using an electrocautery strategy or recombinant follicle stimulating hormone to induce ovulation in polycystic ovary syndrome: randomised controlled trial. BMJ. 2004 Jan 24;328(7433):192. doi: 10.1136/bmj.328.7433.192.
Results Reference
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PubMed Identifier
17636653
Citation
Farquhar C, Lilford RJ, Marjoribanks J, Vandekerckhove P. Laparoscopic 'drilling' by diathermy or laser for ovulation induction in anovulatory polycystic ovary syndrome. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD001122. doi: 10.1002/14651858.CD001122.pub3.
Results Reference
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Combined Metformin and Clomiphene Citrate (CC) or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome (PCOS)
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