Combined Metformin and Clomiphene Citrate (CC) or Laparoscopic Ovarian Diathermy for Women With CC Resistant Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome Clinical Trial

Official title:

Combined Metformin and Clomiphene Citrate Versus Laparoscopic Ovarian Diathermy for Ovulation Induction in Clomiphene-resistant Women With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00969631
• Other study ID #: MU- 012
• Secondary ID: FMH-009-C
• Status: Completed
• Phase: N/A
• First received: August 31, 2009
• Last updated: August 31, 2009
• Start date: September 2005
• Est. completion date: February 2009

Study information

• Verified date: August 2009
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 282
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 36 Years

Eligibility

Inclusion Criteria:

• CC resistant PCOS

Exclusion Criteria:

• Congenital adrenal hyperplasia

• Cushing syndrome

• Androgen secreting tumors

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.

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.

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitals, OB/GYN department	Mansoura	Dakahlia Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View 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. Review. Update in: Cochrane Database Syst Rev. 2012;6:CD001122. — View 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. Epub 2006 Sep 27. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of ovulation and midcycle endometrial thickness (mm).			No
Secondary	occurrence of pregnancy, miscarriage, multiple pregnancy and live birth rates.			No