Infertility and Endometriosis Cohort

Infertility Clinical Trial

— EndoFertil  

Official title:

Infertility and Endometriosis : a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01833013
• Other study ID #: 9113
• Status: Recruiting
• Phase: N/A
• First received: April 11, 2013
• Last updated: January 8, 2015
• Start date: April 2013
• Est. completion date: October 2018

Study information

• Verified date: April 2013
• Source: University Hospital, Montpellier
• Contact: Herve Dechaud, MD,PhD
• Phone: +33467336532
• Email: h-dechaud[@]chu-montpellier.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 41 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Endometriosis
• Infertility

Intervention

Other:
• live birth date and quality of life assessment

Locations

Country	Name	City	State
France	University Hospital Montpellier	Montpellier	Herault

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Quality of life	Assessment of the quality of life relating to infertility and endometriosis in the 3 years following laparoscopic exploration making the diagnosis of endometriosis.	3 years	No
Secondary	pain symptoms	Assessment of the pain symptoms relating to infertility and endometriosis in the 3 years following laparoscopic exploration making the diagnosis of endometriosis.	3 years	No