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Infertility and Endometriosis Cohort (EndoFertil)

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ClinicalTrials.gov Identifier: NCT01833013
Recruitment Status : Unknown
Verified April 2013 by University Hospital, Montpellier.
Recruitment status was:  Recruiting
First Posted : April 16, 2013
Last Update Posted : January 9, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

April 11, 2013
April 16, 2013
January 9, 2015
April 2013
April 2018   (Final data collection date for primary outcome measure)
live birth date [ Time Frame: 3 years ]
Assessment of the number of live birth in the 3 years following the laparoscopic exploration making the diagnosis of endometriosis
Same as current
Complete list of historical versions of study NCT01833013 on ClinicalTrials.gov Archive Site
  • Quality of life [ Time Frame: 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 [ Time Frame: 3 years ]
    Assessment of the pain symptoms relating to infertility and endometriosis in the 3 years following laparoscopic exploration making the diagnosis of endometriosis.
Same as current
Not Provided
Not Provided
 
Infertility and Endometriosis Cohort
Infertility and Endometriosis : a Prospective Cohort Study

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.

Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
  • Endometriosis
  • Infertility
Other: live birth date and quality of life assessment
endometriosis cohort
females suffer from endometriosis
Intervention: Other: live birth date and quality of life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
Same as current
October 2018
April 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
18 Years to 41 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01833013
9113
No
Not Provided
Not Provided
University Hospital, Montpellier
University Hospital, Montpellier
Not Provided
Principal Investigator: Herve Dechaud, MD,PhD University Hospital, Montpellier
University Hospital, Montpellier
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP