Role of Laparoscopy in Unexplained Infertility

NCT ID: NCT00886041

Last Updated: 2009-04-22

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

512 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2008-12-31

Brief Summary

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In this randomized controlled trial the investigators were looking for the best policy for management of women with unexplained infertility after normal hysterosalpingogram (HSG). The investigators test the hypothesis that postponing or even bypassing laparoscopy does not affect the outcome of management of women with apparently unexplained infertility.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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laparoscopy group

laparoscopy

Group Type OTHER

laparoscopy

Intervention Type PROCEDURE

subjected to laparoscopy

ovarian stimulation group

ovarian stimulation and timed intercourse for 3 cycles followed by ovarian stimulation and intrauterine insemination for another 3 cycles

Group Type ACTIVE_COMPARATOR

ovarian stimulation

Intervention Type OTHER

ovarian stimulation and timed intercourse for 3 cycles followed by ovarian stimulation and intrauterine insemination for another 3 cycles

Interventions

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laparoscopy

subjected to laparoscopy

Intervention Type PROCEDURE

ovarian stimulation

ovarian stimulation and timed intercourse for 3 cycles followed by ovarian stimulation and intrauterine insemination for another 3 cycles

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* failure of conception for at least one year
* no pathology demonstrated after the standard infertility work-up including semen analysis, mid-luteal serum progesterone for confirming ovulation and hysterosalpingography for documenting tubal patency
* diagnosed as having unexplained infertility
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Principal Investigators

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ahmed m badawy, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Mansoura University Hospitals

Al Mansurah, Dakahalia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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mansoura university

Identifier Type: -

Identifier Source: org_study_id

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