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OpenTrials
Completed

NCT Number: NCT01675843

Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome

The study null hypothethesis is: intrauterine insemination (IUI) does not improve pregnancy rates in women with polycystic ovary syndrome. Infertile women with pcos will receive gonadotropins for ovarian stimulation and then randomize to either IUI or timed intercourse (TI)

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Key information

Conditions

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

Age range

21 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Fertility Care Unit

Al Mansurah, Eldakahlia, 53111, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • women who failed to get pregnant after 6 ovulation induction cycles with clomiphene citrate (cc) alone, despite of being ovulating with cc, having patent Fallopian tubes as confirmed by hysterosalpingography and their partners had fertile semen parameters according to criteria of World Health Organization (WHO 2010)

Exclusion criteria

male factor infertility

Treatment and study plan

Intrauterine insemination (IUI)

Procedure

The male semen is obtained then processed by swim up technique and then introduced into the uterus by special catheter.

Other names: IUI

Primary outcomes

  1. Live Birth Rate

    Time frame: 20 months

Secondary outcomes

  1. Clinical pregnancy rate

    Time frame: 16 months

Other outcomes

  1. multiple pregnancy rate

    Time frame: 20 months

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Acronym: OSIPS

Important dates

Study start
2010
Primary completion
2012
First posted
Aug 30, 2012
Registry last updated
Aug 30, 2012

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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