Infertility and Endometriosis Cohort

Not Applicable

• Conditions: Endometriosis; Infertility
• Interventions: Other: live birth date and quality of life assessment

• Registration Number: NCT01833013
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

Nowadays, one in six couples consults for fertility problems. If the standard examination and tests do not reveal any cause of infertility, the woman may undergo a laparoscopic exploration which reveals endometriosis in more than 50% of cases.

Endometriosis is an inflammatory disease defined as the presence of endometrial tissue out of the uterine cavity. It is frequent (1 in 10 women) and associated with a high economic burden (22 billion dollars in 2002 in the USA) and important decrease in quality of life. Physiopathological mechanisms and risk factors for endometriosis are not well identified.

A woman with endometriosis is 20 times more at risk of infertility. Fecundity rate of a 25-year-old couple is about 15 to 20% in the general population and only 2 to 10% in case of endometriosis.

There are many manifestations of this disease (infertility, pelvic pain) and the anatomo-clinical correlation is not good. The presently used international classification (American Fertility Society revised in 1985, AFSr) does not predict the chance of pregnancy. New scores such as the Endometriosis Fertility Index (EFI) have been proposed to do so, but need to be validated. Treatment for endometriosis-related infertility is not consensual.

A prospective cohort study would give access to clinical data of patients followed in our center, so as to identify clinical factors predicting pregnancy and to help treatment decision for women with endometriosis suffering from infertility.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-04
• Study Start: 2013-04
• Study First Submitted: 2013-04-11
• Study First Submitted QC: 2013-04-11
• Study First Posted: 2013-04-16
• Last Update Submitted: 2015-01-08
• Last Update Posted: 2015-01-09
• Primary Completion: 2018-04
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
endometriosis cohort	live birth date and quality of life assessment	females suffer from endometriosis

Primary Outcome Measures

Name	Time	Method
live birth date	3 years	Assessment of the number of live birth in the 3 years following the laparoscopic exploration making the diagnosis of endometriosis

Secondary Outcome Measures

Name	Time	Method
Quality of life	3 years	Assessment of the quality of life relating to infertility and endometriosis in the 3 years following laparoscopic exploration making the diagnosis of endometriosis.
pain symptoms	3 years	Assessment of the pain symptoms relating to infertility and endometriosis in the 3 years following laparoscopic exploration making the diagnosis of endometriosis.

Trial Locations

Locations (1)

University Hospital Montpellier; 🇫🇷 Montpellier, Herault, France