EndoFertil: Infertility and Endometriosis Cohort

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Unknown status

CT.gov ID

NCT01833013

Collaborator

(none)

200

Enrollment

Location

Arm

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis Infertility	Other: live birth date and quality of life assessment	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

Infertility and Endometriosis : a Prospective Cohort Study

Study Start Date :

Apr 1, 2013

Anticipated Primary Completion Date :

Apr 1, 2018

Anticipated Study Completion Date :

Oct 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: endometriosis cohort females suffer from endometriosis	Other: live birth date and quality of life assessment

Arm

Intervention/Treatment

Other: endometriosis cohort

females suffer from endometriosis

Other: live birth date and quality of life assessment

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 41 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion criteria:

Woman from 18 to 41 years old.
Dealing with infertility,
With a normal pelvic echography and hysterosalpingography, a normal hormonal status and a partner with a normal sperm.
For whom a laparoscopic exploration finds endometriosis.
Consenting to participate to the study.