Infertility and Endometriosis Cohort

Study Overview
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Brief Summary
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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.

Official Title
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Infertility and Endometriosis : a Prospective Cohort Study

Conditions
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Endometriosis, Infertility

Intervention / Treatment
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* Other: live birth date and quality of life assessment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 41 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: endometriosis cohort<br>females suffer from endometriosis | Other: live birth date and quality of life assessment<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometriosis, Cohort study, fertility, pregnancy, assisted reproductive technics, laparoscopy