NCT01675843

Brief Summary

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)

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed
Last Updated

August 30, 2012

Status Verified

August 1, 2012

Enrollment Period

1.8 years

First QC Date

August 28, 2012

Last Update Submit

August 28, 2012

Conditions

InfertilityPolycystic Ovarian SyndromeIntrauterine Insemination

Keywords

InfertilityPCOSIUI

Outcome Measures

Primary Outcomes (1)

  • Live Birth Rate

    20 months

Secondary Outcomes (1)

  • Clinical pregnancy rate

    16 months

Other Outcomes (1)

  • multiple pregnancy rate

    20 months

Study Arms (2)

Group A

EXPERIMENTAL

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

Procedure: Intrauterine insemination (IUI)

Group B

NO INTERVENTION

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

Interventions

Intrauterine insemination (IUI)PROCEDURE

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

Also known as: IUI
Group A

Eligibility Criteria

Age21 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \- 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)

You may not qualify if:

  • male factor infertility

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Care Unit

Al Mansurah, Eldakahlia, 53111, Egypt

Location

MeSH Terms

Conditions

InfertilityPolycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesOvarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGonadal DisordersEndocrine System Diseases

Study Officials

  • Ahmed Gibreel, MD

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

August 28, 2012

First Posted

August 30, 2012

Study Start

May 1, 2010

Primary Completion

March 1, 2012

Last Updated

August 30, 2012

Record last verified: 2012-08

Locations

EG(1)