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Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome

NCT ID: NCT01675843

Last Updated: 2012-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Brief Summary

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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)

Detailed Description

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Conditions

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Infertility Polycystic Ovarian Syndrome Intrauterine Insemination

Keywords

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Infertility PCOS IUI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group A

controlled ovarian hyperstimulation (COH) and intrauterine insemination (IUI)

Group Type EXPERIMENTAL

Intrauterine insemination (IUI)

Intervention Type PROCEDURE

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

Group B

Controlled ovarian hyperstimulation (COH)+ Timed Intercourse (TI)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intrauterine insemination (IUI)

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

Intervention Type PROCEDURE

Other Intervention Names

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IUI

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Gibreel

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed Gibreel, MD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Fertility Care Unit

Al Mansurah, Eldakahlia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AG/4/2010

Identifier Type: -

Identifier Source: org_study_id