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OpenTrials
Completed

NCT Number: NCT00969631

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

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Urogenital Diseases

Age range

20 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University Hospitals, OB/GYN department

Al Mansurah, Dakahlia Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • CC resistant PCOS

Exclusion criteria

  • Congenital adrenal hyperplasia
  • Cushing syndrome
  • Androgen secreting tumors

Treatment and study plan

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.

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.

Primary outcomes

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 1, 2009
Registry last updated
Sep 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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