Infertility and Endometriosis Cohort

NCT ID: NCT01833013

Last Updated: 2015-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2018-10-31

Brief Summary

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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

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Conditions

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Endometriosis Infertility

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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endometriosis cohort

females suffer from endometriosis

Group Type OTHER

live birth date and quality of life assessment

Intervention Type OTHER

Interventions

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live birth date and quality of life assessment

Intervention Type OTHER

Eligibility Criteria

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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.

Exclusion Criteria

* Any contraindication for general anesthesia or for laparoscopy.
* Any contraindication for pregnancy.
* Follow-up is impossible.
* Consent is impossible.
Minimum Eligible Age

18 Years

Maximum Eligible Age

41 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Herve Dechaud, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Montpellier

Locations

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University Hospital Montpellier

Montpellier, Herault, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Herve Dechaud, MD,PhD

Role: CONTACT

+33467336532

claire chauveton, pharmD

Role: CONTACT

+33467330924

Facility Contacts

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Herve Dechaud, MD,PhD

Role: primary

+33467336532

claire chauveton, PharmD

Role: backup

+33467330924

Other Identifiers

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9113

Identifier Type: -

Identifier Source: org_study_id

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