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Completed

NCT Number: NCT01157312

Minimal Stimulation or Clomiphene Citrate in Treatment of Polycystic Ovary Syndrome

The purpose of this study is to compare and determine the the efficacy of minimal stimulation and clomiphene citrate(CC) as the first-line treatment in infertile women with Polycystic Ovary Syndrome(PCOS).

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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–39 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 received 100 mg CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) for 5 days starting from day 3 of spontaneous or induced menstruation. In group A (minimal stimulation), 2 vials of highly purified uFSH , 150 IU (Fostimon; IBSA, Lugano, Switzerland, 75 IU/vial) were given IM on cycle day 9. A total of 3 cycles was offered to each group.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • PCOS
  • No other infertility factors
  • No previous use of ovarian stimulation drugs

Exclusion criteria

  • Congenital adrenal hyperplasia
  • Cushing syndrome
  • Androgen secreting tumors

Treatment and study plan

clomiphene citrate +highly purified uFSH

Drug

Clomiphene Citrate

Drug

Primary outcomes

  1. clinical pregnancy rate per cycle

Secondary outcomes

  1. endometrial thickness at the time of hCG administration

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Minimal Stimulation or Clomiphene Citrate as First Line Therapy in Women With Polycystic Ovary Syndrome

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 7, 2010
Registry last updated
Jul 19, 2010

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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