Unexplained Infertility Treated by Hysteroscopy-laparoscopy

NCT04465045 | Completed

• 1 other identifier: RECHMPL20_0084
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Unexplained Infertility

Keywords

Ovulation; semen analysis; tubal patency; pelvic ultrasound scan

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  pregnancy with an hearbeat on a pelvic ultrasound scan

  1 day

Secondary Outcomes (6)

• Number of Participants with miscarriage

  1 day

• live birth rate

  1 day

• Number of Participants with fœtal losses

  1 day

• Number of Participants with ectopic pregnancy

  1 day

• Number of Participants with surgical complications

  1 day

Study Arms (1)

Unique cohort

All women, 18 to 43 years, operated from laparoscopy-hysteroscopy for unexplained infertility in montpellier university hospital

Procedure: Laparoscopy-hysteroscopy

Interventions

Laparoscopy-hysteroscopy PROCEDURE

Under general anesthesia, we start by a first look in laparoscopy, to look for endometriosis mainly, tubal infertility, ovarian cysts or any abnormalities that may not have been suspected on the first exam. Then we check tubal patency after a look at the uterine cavity by hysteroscopy. Then we treat everything possible to treat to improve fertility, spontaneous or with ART.

Unique cohort

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

In Montpellier University center only, France : from january 2013 to december 2018 unexplained infertile couple, trying to conceive for more than one year and operated by laparoscopy-hysteroscopy

You may qualify if:

• unexplained infertility
• operated from laparoscopy-hysteroscopy at montpellier university hospital

You may not qualify if:

• an IMR that diagnoses formelly an endometriosis, or endometriosic ovarian cysts
• non respect of our definition of unexplained infertility (such as bilateral tubal issue on hysterosalpingograms)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

some endometrial biopsy

Study Officials

• Claire Vincens, doctor of medecine

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 9, 2020
• Study Start: June 1, 2020
• Primary Completion: September 30, 2020
• Study Completion: October 1, 2020
• Last Updated: December 29, 2020

Record last verified: 2020-12

Locations

FR (1)