NCT00969631

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
282

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2009

Completed
Last Updated

September 1, 2009

Status Verified

August 1, 2009

Enrollment Period

3.4 years

First QC Date

August 31, 2009

Last Update Submit

August 31, 2009

Conditions

Polycystic Ovary Syndrome

Keywords

Polycystic ovary syndromeclomiphene resistancemetforminlaparoscopic ovarian diathermy

Outcome Measures

Primary Outcomes (1)

  • occurrence of ovulation and midcycle endometrial thickness (mm).

Secondary Outcomes (1)

  • occurrence of pregnancy, miscarriage, multiple pregnancy and live birth rates.

Study Arms (2)

Metformin-CC

EXPERIMENTAL
Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt), CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt),Cairo, Egypt)

Laparoscopic ovarian diathermy (LOD)

ACTIVE COMPARATOR
Procedure: Laparoscopic ovarian diathermy (LOD)

Interventions

metformin HCl (Cidophage®; CID,Cairo, Egypt), CC (Clomid®; Global Napi Pharmaceuticals,Cairo, Egypt),Cairo, Egypt)DRUG

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.

Metformin-CC
Laparoscopic ovarian diathermy (LOD)PROCEDURE

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.

Laparoscopic ovarian diathermy (LOD)

Eligibility Criteria

Age20 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • CC resistant PCOS

You may not qualify if:

  • Congenital adrenal hyperplasia
  • Cushing syndrome
  • Androgen secreting tumors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospitals, OB/GYN department

Al Mansurah, Dakahlia Governorate, Egypt

Location

Related Publications (3)

  • 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.

    PMID: 17007847BACKGROUND

  • 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.

    PMID: 14739186BACKGROUND

  • 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.

    PMID: 17636653BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

MetforminClomiphene

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Hatem Abu Hashim, MD. MRCOG

    Mansoura University Hospital

    PRINCIPAL INVESTIGATOR

  • Naser El Lakany, MD

    Mansoura University Hospital

    STUDY DIRECTOR

  • Lotfi Sherief, MD

    Mansoura University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2009

First Posted

September 1, 2009

Study Start

September 1, 2005

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

September 1, 2009

Record last verified: 2009-08

Locations

EG(1)