Role of Laparoscopy in Unexplained Infertility

Mansoura University

Status and phase: Completed; Phase 4

Conditions: Infertility

Treatments: Procedure: laparoscopy; Other: ovarian stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00886041

mansoura university

Details and patient eligibility

About

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.

Enrollment: 512 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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512 participants in 2 patient groups

laparoscopy group

Other group

Description:

laparoscopy

Treatment:

Procedure: laparoscopy

ovarian stimulation group

Active Comparator group

Description:

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

Treatment:

Other: ovarian stimulation