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Unexplained Infertility Treated by Hysteroscopy-laparoscopy

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04465045
Enrollment
250
Registered
2020-07-09
Start date
2020-06-01
Completion date
2020-10-01
Last updated
2020-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unexplained Infertility

Keywords

Ovulation, semen analysis, tubal patency, pelvic ultrasound scan

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.

Interventions

PROCEDURELaparoscopy-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.

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 43 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
clinical pregnancy rate1 daypregnancy with an hearbeat on a pelvic ultrasound scan

Secondary

MeasureTime frameDescription
live birth rate1 daylive birth rate : birth of a viable foetus after 24 SA
Number of Participants with fœtal losses1 dayNumber of Participants with Foetal losses : loss of a non viable foetus, before 24 SA
Number of Participants with miscarriage1 dayNumber of Participants with miscarriage : positive pregnancy blood test, resulting in bleeding
Number of Participants with surgical complications1 dayNumber of Participants withSurgical complications : during surgery, and a few days after surgery
Number of Participants with type of surgery1 dayNumber of Participants with type of surgery: tubal surgeries, adhesiolysis, endometriosis surgeries, hysteroscopic gestures.
Number of Participants with ectopic pregnancy1 dayNumber of Participants with ectopic pregnancy: tubal pregnancy highly suspected by blood test or seen on a pelvic ultrasound scan

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026