Unexplained Infertility Treated by Hysteroscopy-laparoscopy

Completed

• Conditions: Unexplained Infertility
• Interventions: Procedure: Laparoscopy-hysteroscopy

• Registration Number: NCT04465045
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Retrospective study, including patients from january 2013 to december 2018, who were diagnosed with unexplained infertility : spontaneously ovulating women with normal pelvic ultrasound scan, patent tubes on hysterosalpingography and normal pelvic exam or pelvic MRI normal. Semen analyses were normal according to the World Health Organization criteria. Couples were referred for diagnostic laparoscopy and hysteroscopy. They were then addressed for spontaneous fertility or ART to conceive. The investigators would like to see how many surgeries were useful to assess a diagnostic, and if operating allows a satisfying pregnancy rate. The investigators would like to assess how many diagnosis was done after surgery and how many pregnancy were obtained. The investigators search other prognostic factors than age or parity.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-07-06
• Study First Submitted QC: 2020-07-06
• Study First Posted: 2020-07-09
• Primary Completion: 2020-09-30
• Study Completion: 2020-10-01
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-28
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Unique cohort	Laparoscopy-hysteroscopy	All women, 18 to 43 years, operated from laparoscopy-hysteroscopy for unexplained infertility in montpellier university hospital

Primary Outcome Measures

Name	Time	Method
clinical pregnancy rate	1 day	pregnancy with an hearbeat on a pelvic ultrasound scan

Secondary Outcome Measures

Name	Time	Method
Number of Participants with miscarriage	1 day	Number of Participants with miscarriage : positive pregnancy blood test, resulting in bleeding
live birth rate	1 day	live birth rate : birth of a viable foetus after 24 SA
Number of Participants with fœtal losses	1 day	Number of Participants with Foetal losses : loss of a non viable foetus, before 24 SA
Number of Participants with ectopic pregnancy	1 day	Number of Participants with ectopic pregnancy: tubal pregnancy highly suspected by blood test or seen on a pelvic ultrasound scan
Number of Participants with type of surgery	1 day	Number of Participants with type of surgery: tubal surgeries, adhesiolysis, endometriosis surgeries, hysteroscopic gestures.
Number of Participants with surgical complications	1 day	Number of Participants withSurgical complications : during surgery, and a few days after surgery

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France