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Completed

NCT Number: NCT04465045

Unexplained Infertility Treated by Hysteroscopy-laparoscopy

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.

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Key information

Conditions

Unexplained Infertility

Age range

18 year–43 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. clinical pregnancy rate

    Time frame: 1 day

    pregnancy with an hearbeat on a pelvic ultrasound scan

Secondary outcomes

  1. Number of Participants with miscarriage

    Time frame: 1 day

    Number of Participants with miscarriage : positive pregnancy blood test, resulting in bleeding

  2. live birth rate

    Time frame: 1 day

    live birth rate : birth of a viable foetus after 24 SA

  3. Number of Participants with fœtal losses

    Time frame: 1 day

    Number of Participants with Foetal losses : loss of a non viable foetus, before 24 SA

  4. Number of Participants with ectopic pregnancy

    Time frame: 1 day

    Number of Participants with ectopic pregnancy: tubal pregnancy highly suspected by blood test or seen on a pelvic ultrasound scan

  5. Number of Participants with surgical complications

    Time frame: 1 day

    Number of Participants withSurgical complications : during surgery, and a few days after surgery

  6. Number of Participants with type of surgery

    Time frame: 1 day

    Number of Participants with type of surgery: tubal surgeries, adhesiolysis, endometriosis surgeries, hysteroscopic gestures.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 9, 2020
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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