Infertility and Endometriosis Cohort

NCT01833013 | Unknown

• 1 other identifier: 9113
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis; Infertility

Keywords

Endometriosis; Cohort study; fertility; pregnancy; assisted reproductive technics; laparoscopy

Outcome Measures

Primary Outcomes (1)

• live birth date

  Assessment of the number of live birth in the 3 years following the laparoscopic exploration making the diagnosis of endometriosis

  3 years

Secondary Outcomes (2)

• Quality of life

  3 years

• pain symptoms

  3 years

Study Arms (1)

endometriosis cohort

OTHER

females suffer from endometriosis

Other: live birth date and quality of life assessment

Interventions

live birth date and quality of life assessment OTHER

endometriosis cohort

Eligibility Criteria

• Age: 18 Years - 41 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Any contraindication for general anesthesia or for laparoscopy.
• Any contraindication for pregnancy.
• Follow-up is impossible.
• Consent is impossible.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

University Hospital Montpellier

Montpellier, Herault, 34295, France

RECRUITING

MeSH Terms

Conditions

Endometriosis; Infertility

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Herve Dechaud, MD,PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Herve Dechaud, MD,PhD

CONTACT

+33467336532; h-dechaud@chu-montpellier.fr

claire chauveton, pharmD

CONTACT

+33467330924; c-chauveton@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2013
• First Posted: April 16, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: October 1, 2018
• Last Updated: January 9, 2015

Record last verified: 2013-04

Locations

FR (1)