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Completed

NCT Number: NCT02910817

Impact of Metformin on In Vitro Fertilization Outcomes in Overweight and Obese PCOS Women

RCT to investigate whether metformin co-treatment would improve IVF outcomes in overweight and obese women with 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–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University

Asyut, 71515, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The inclusion criteria restricted the patients to 39 years old with basal FSH < 10 IU/ml and normal TSH and prolacin.

Exclusion criteria

  • Exclusion criteria were diabetes mellitus (excluded by GTT), renal or liver disease, associated male factor, documented tubal factor or pelvic adhesions, elevated 17 alfa hydroxyprogesterone level and FSH ≥10 IU/ml. We also excluded the women who started program or medications to reduce their weight and those who their partner has abnormal semen parameters according to the world health organization parameters (WHO, 2010)

Treatment and study plan

metformin

Drug

The metformin-treated group received metformin (1000 mg per day) with the start of controlled ovarian stimulation (COH) until the day of the pregnancy check.

Placebo

Other

Placebo

Primary outcomes

  1. Total number of retrieved oocytes

    Time frame: Two weeks Metformin treatment

Secondary outcomes

  1. Live birth rate

    Time frame: End of the pregnancy

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Impact of Metformin on In Vitro Fertilization Outcomes in Overweight and Obese Polycystic Ovary Syndrome Women; A Quasi Experimental Study

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 22, 2016
Registry last updated
Nov 14, 2017

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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