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Unexplained Infertility Treated by Hysteroscopy-laparoscopy

NCT ID: NCT04465045

Last Updated: 2020-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-10-01

Brief Summary

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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

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Conditions

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Unexplained Infertility

Keywords

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Ovulation semen analysis tubal patency pelvic ultrasound scan

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Unique cohort

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

Laparoscopy-hysteroscopy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

* non respect of our definition of unexplained infertility (such as bilateral tubal issue on hysterosalpingograms)

Exclusion Criteria

* an IMR that diagnoses formelly an endometriosis, or endometriosic ovarian cysts
Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claire Vincens, doctor of medecine

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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RECHMPL20_0084

Identifier Type: -

Identifier Source: org_study_id