Back to resultsRole of Laparoscopy in Unexplained Infertility
Primary Purpose
Infertility
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
laparoscopy
ovarian stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring laparoscopy, unexplained infertility
Eligibility 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
Sites / Locations
- Mansoura University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
laparoscopy group
ovarian stimulation group
Arm Description
laparoscopy
ovarian stimulation and timed intercourse for 3 cycles followed by ovarian stimulation and intrauterine insemination for another 3 cycles
Outcomes
Primary Outcome Measures
The outcome measure was the occurrence of clinical pregnancy and miscarriage.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00886041
Brief Title
Role of Laparoscopy in Unexplained Infertility
Official Title
Role of Laparoscopy in Unexplained Infertility
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
laparoscopy, unexplained infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
512 (Actual)
8. Arms, Groups, and Interventions
Arm Title
laparoscopy group
Arm Type
Other
Arm Description
laparoscopy
Arm Title
ovarian stimulation group
Arm Type
Active Comparator
Arm Description
ovarian stimulation and timed intercourse for 3 cycles followed by ovarian stimulation and intrauterine insemination for another 3 cycles
Intervention Type
Procedure
Intervention Name(s)
laparoscopy
Intervention Description
subjected to laparoscopy
Intervention Type
Other
Intervention Name(s)
ovarian stimulation
Intervention Description
ovarian stimulation and timed intercourse for 3 cycles followed by ovarian stimulation and intrauterine insemination for another 3 cycles
Primary Outcome Measure Information:
Title
The outcome measure was the occurrence of clinical pregnancy and miscarriage.
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ahmed m badawy, MD PhD
Organizational Affiliation
Mansoura University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mansoura University Hospitals
City
Mansoura
State/Province
Dakahalia
ZIP/Postal Code
35000
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Role of Laparoscopy in Unexplained Infertility
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