Unexplained Infertility Treated by Hysteroscopy-laparoscopy

Unexplained Infertility Treated by Hysteroscopy-laparoscopy : Predictive Factors of Pregnancy

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.

Study Overview

• Status: Completed
• Conditions: Unexplained Infertility
• Intervention / Treatment: Procedure: Laparoscopy-hysteroscopy

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion criteria:

• 18-43y
• unexplained infertility
• operated from laparoscopy-hysteroscopy at montpellier university hospital

Exclusion criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Procedure: Laparoscopy-hysteroscopy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy rate	pregnancy with an hearbeat on a pelvic ultrasound scan	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Claire Vincens, doctor of medecine, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): September 30, 2020
• Study Completion (Actual): October 1, 2020

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Ovulation; tubal patency; semen analysis; pelvic ultrasound scan
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: RECHMPL20_0084

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No