Role of Laparoscopy in Unexplained Infertility

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT00886041
First received: April 21, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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 Intervention Phase
Infertility
Procedure: laparoscopy
Other: ovarian stimulation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role of Laparoscopy in Unexplained Infertility

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • The outcome measure was the occurrence of clinical pregnancy and miscarriage. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 512
Study Start Date: January 2003
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders 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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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: professor ahmed m badawy
ClinicalTrials.gov Identifier: NCT00886041     History of Changes
Other Study ID Numbers: mansoura university
Study First Received: April 21, 2009
Last Updated: April 21, 2009
Health Authority: Egypt: Mansoura faculty of medicine

Keywords provided by Mansoura University:
laparoscopy
unexplained infertility

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

ClinicalTrials.gov processed this record on October 29, 2014