Infertility and Endometriosis Cohort (EndoFertil)

This study is not yet open for participant recruitment.
Verified April 2013 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01833013
First received: April 11, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted
  Purpose

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 Intervention
Endometriosis
Infertility
Other: live birth date and quality of life assessment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Infertility and Endometriosis : a Prospective Cohort Study

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • live birth date [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Assessment of the pain symptoms relating to infertility and endometriosis in the 3 years following laparoscopic exploration making the diagnosis of endometriosis.


Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
endometriosis cohort
females suffer from endometriosis
Other: live birth date and quality of life assessment

  Eligibility

Ages Eligible for Study:   18 Years to 41 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01833013

Contacts
Contact: Herve Dechaud, MD,PhD +33467336532 h-dechaud@chu-montpellier.fr
Contact: claire chauveton, pharmD +33467330924 c-chauveton@chu-montpellier.fr

Locations
France
University Hospital Montpellier Not yet recruiting
Montpellier, Herault, France, 34295
Contact: Herve Dechaud, MD,PhD    +33467336532    h-dechaud@chu-montpellier.fr   
Contact: claire chauveton, PharmD    +33467330924    c-chauveton@chu-montpellier.fr   
Principal Investigator: Herve Dechaud, MD,PhD         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Herve Dechaud, MD,PhD University Hospital, Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01833013     History of Changes
Other Study ID Numbers: 9113
Study First Received: April 11, 2013
Last Updated: April 11, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by University Hospital, Montpellier:
Endometriosis
Cohort study
fertility
pregnancy
assisted reproductive technics
laparoscopy

Additional relevant MeSH terms:
Endometriosis
Infertility
Genital Diseases, Female
Genital Diseases, Male

ClinicalTrials.gov processed this record on April 16, 2014