NCT00886041

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
512

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2003

Longer than 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

January 1, 2003

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
Last Updated

April 22, 2009

Status Verified

April 1, 2009

Enrollment Period

5.9 years

First QC Date

April 21, 2009

Last Update Submit

April 21, 2009

Conditions

Infertility

Keywords

laparoscopyunexplained infertility

Outcome Measures

Primary Outcomes (1)

  • The outcome measure was the occurrence of clinical pregnancy and miscarriage.

    5 years

Study Arms (2)

laparoscopy group

OTHER

laparoscopy

Procedure: laparoscopy

ovarian stimulation group

ACTIVE COMPARATOR

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

Other: ovarian stimulation

Interventions

laparoscopyPROCEDURE

subjected to laparoscopy

laparoscopy group
ovarian stimulationOTHER

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

ovarian stimulation group

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospitals

Al Mansurah, Dakahalia, 35000, Egypt

Location

MeSH Terms

Conditions

Infertility

Interventions

LaparoscopyOvulation Induction

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeReproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • ahmed m badawy, MD PhD

    Mansoura University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 21, 2009

First Posted

April 22, 2009

Study Start

January 1, 2003

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

April 22, 2009

Record last verified: 2009-04

Locations

EG(1)