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:

MedlinePlus related topics: Infertility

U.S. FDA Resources

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 February 25, 2015

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