Unexplained Infertility Treated by Hysteroscopy-laparoscopy

Unexplained Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04465045
• Other study ID #: RECHMPL20_0084
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: October 1, 2020

Study information

• Verified date: December 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: October 1, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 43 Years

Eligibility

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)

Related Conditions & MeSH terms

• Infertility
• Unexplained Infertility

Intervention

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.

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical pregnancy rate	pregnancy with an hearbeat on a pelvic ultrasound scan	1 day
Secondary	Number of Participants with miscarriage	Number of Participants with miscarriage : positive pregnancy blood test, resulting in bleeding	1 day
Secondary	live birth rate	live birth rate : birth of a viable foetus after 24 SA	1 day
Secondary	Number of Participants with fœtal losses	Number of Participants with Foetal losses : loss of a non viable foetus, before 24 SA	1 day
Secondary	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
Secondary	Number of Participants with surgical complications	Number of Participants withSurgical complications : during surgery, and a few days after surgery	1 day
Secondary	Number of Participants with type of surgery	Number of Participants with type of surgery: tubal surgeries, adhesiolysis, endometriosis surgeries, hysteroscopic gestures.	1 day