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Role of Laparoscopy in Unexplained Infertility

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ClinicalTrials.gov Identifier: NCT00886041
Recruitment Status : Completed
First Posted : April 22, 2009
Last Update Posted : April 22, 2009
Sponsor:
Information provided by:
Mansoura University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infertility Procedure: laparoscopy Other: ovarian stimulation Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 512 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Role of Laparoscopy in Unexplained Infertility
Study Start Date : January 2003
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
laparoscopy group
laparoscopy
 Procedure: laparoscopy
subjected to laparoscopy
Active Comparator: ovarian stimulation group
ovarian stimulation and timed intercourse for 3 cycles followed by ovarian stimulation and intrauterine insemination for another 3 cycles
 Other: ovarian stimulation
ovarian stimulation and timed intercourse for 3 cycles followed by ovarian stimulation and intrauterine insemination for another 3 cycles


Outcome Measures
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Primary Outcome Measures :
  1. The outcome measure was the occurrence of clinical pregnancy and miscarriage. [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886041


Locations
Egypt
Mansoura University Hospitals
Mansoura, Dakahalia, Egypt, 35000
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: ahmed m badawy, MD PhD Mansoura University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: professor ahmed m badawy
ClinicalTrials.gov Identifier: NCT00886041     History of Changes
Other Study ID Numbers: mansoura university
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: April 22, 2009
Last Verified: April 2009

Keywords provided by Mansoura University:
laparoscopy
unexplained infertility

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female