Suspended

EndoFertilInfertility and Endometriosis : a Prospective Cohort Study

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

live birth date and quality of life assessment

Other
Who is being recruted

Urogenital Diseases+4

+ Genital Diseases

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 41 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Interventional
Study Start: April 2013
See protocol details

Summary

Principal SponsorUniversity Hospital, Montpellier
Study ContactHerve Dechaud, MD,PhDMore contacts
Last updated: January 9, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity Hospital, Montpellier
Study ContactHerve Dechaud, MD,PhDMore contacts
Last updated: January 9, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

200 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 41 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleFemale Urogenital DiseasesEndometriosisInfertility

Criteria

5 inclusion criteria required to participate
Consenting to participate to the study

Dealing with infertility

For whom a laparoscopic exploration finds endometriosis

With a normal pelvic echography and hysterosalpingography, a normal hormonal status and a partner with a normal sperm

Show More Criteria

4 exclusion criteria prevent from participating
Any contraindication for general anesthesia or for laparoscopy

Any contraindication for pregnancy

Consent is impossible

Follow-up is impossible

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

females suffer from endometriosis

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

University Hospital Montpellier

Montpellier, FranceOpen University Hospital Montpellier in Google Maps
SuspendedOne Study Center