Unexplained Infertility Treated by Hysteroscopy-laparoscopy

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Completed

CT.gov ID

NCT04465045

Collaborator

(none)

250

Enrollment

Location

Actual Duration (Months)

62.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Unexplained Infertility	Procedure: Laparoscopy-hysteroscopy

Study Design

Study Type:

Observational

Actual Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2020

Actual Primary Completion Date :

Sep 30, 2020

Actual Study Completion Date :

Oct 1, 2020

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

clinical pregnancy rate [1 day]
pregnancy with an hearbeat on a pelvic ultrasound scan

Secondary Outcome Measures

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 surgical complications [1 day]
Number of Participants withSurgical complications : during surgery, and a few days after surgery
Number of Participants with type of surgery [1 day]
Number of Participants with type of surgery: tubal surgeries, adhesiolysis, endometriosis surgeries, hysteroscopic gestures.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 43 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uhmontpellier	Montpellier		France	34295

Sponsors and Collaborators

University Hospital, Montpellier

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Montpellier

ClinicalTrials.gov Identifier:

NCT04465045

Other Study ID Numbers:

RECHMPL20_0084

First Posted:

Jul 9, 2020

Last Update Posted:

Dec 29, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Montpellier

Ovulation

semen analysis

tubal patency

pelvic ultrasound scan

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Dec 29, 2020