Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome (OSIPS)

August 28, 2012 updated by: Ahmed Gibreel, Mansoura University
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)

Study Overview

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Eldakahlia
      • Mansoura, Eldakahlia, Egypt, 53111
        • Fertility Care Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
controlled ovarian hyperstimulation (COH) and intrauterine insemination (IUI)
The male semen is obtained then processed by swim up technique and then introduced into the uterus by special catheter.
Other Names:
  • IUI
No Intervention: Group B
Controlled ovarian hyperstimulation (COH)+ Timed Intercourse (TI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Live Birth Rate
Time Frame: 20 months
20 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy rate
Time Frame: 16 months
16 months

Other Outcome Measures

Outcome Measure
Time Frame
multiple pregnancy rate
Time Frame: 20 months
20 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

August 28, 2012

First Submitted That Met QC Criteria

August 28, 2012

First Posted (Estimate)

August 30, 2012

Study Record Updates

Last Update Posted (Estimate)

August 30, 2012

Last Update Submitted That Met QC Criteria

August 28, 2012

Last Verified

August 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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