Clinical trial NCT00969631: 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
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: Polycystic ovary syndrome
clomiphene resistance
metformin
laparoscopic ovarian diathermy
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2009-09-01
Enrollment: 282
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* CC resistant PCOS

Exclusion Criteria:

* Congenital adrenal hyperplasia
* Cushing syndrome
* Androgen secreting tumors

Primary outcomes:
measure: occurrence of ovulation and midcycle endometrial thickness (mm).
Secondary outcomes:
measure: occurrence of pregnancy, miscarriage, multiple pregnancy and live birth rates.
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals, OB/GYN department
state: Dakahlia Governorate
Study officials:
affiliation: Mansoura University Hospital
name: Hatem Abu Hashim, MD. MRCOG
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University Hospital
name: Naser El Lakany, MD
role: STUDY_DIRECTOR
affiliation: Mansoura University Hospital
name: Lotfi Sherief, MD
role: STUDY_CHAIR
References:
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.
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.
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.