Infertility and Endometriosis Cohort (EndoFertil)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01833013|
Recruitment Status : Recruiting
First Posted : April 16, 2013
Last Update Posted : January 9, 2015
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||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Infertility and Endometriosis : a Prospective Cohort Study|
|Study Start Date :||April 2013|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||October 2018|
females suffer from endometriosis
Other: live birth date and quality of life assessment
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01833013
|Contact: Herve Dechaud, MD,PhDfirstname.lastname@example.org|
|Contact: claire chauveton, pharmDemail@example.com|
|University Hospital Montpellier||Recruiting|
|Montpellier, Herault, France, 34295|
|Contact: Herve Dechaud, MD,PhD +33467336532 firstname.lastname@example.org|
|Contact: claire chauveton, PharmD +33467330924 email@example.com|
|Principal Investigator: Herve Dechaud, MD,PhD|
|Principal Investigator:||Herve Dechaud, MD,PhD||University Hospital, Montpellier|