Fertility Preservation in Case of Endometriosis : Observational Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometriosis
- Sponsor
- Assistance Publique - Hôpitaux de Paris
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- characteristics of patients who will benefit from preservation fertility in case of endometriosis (age, parameters of ovarian reserve, endometriosis stage and lesions, previous treatment or surgeries, previous fertility treatment)
- Status
- Recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
Fertility Preservation is now considered as crucial for the well-being of women battling cancer. However, others indications have more recently emerged. Women with endometriosis may represent a suitable group since they are at risk for compromise ovarian reserve. Data on FP in endometriosis patients are rare: only small retrospective study, case-reports and opinion publications .Nowadays, there is no available data concerning real indications for PF on endometriosis patients (endometriomas, risk of surgery, deep endometriosis?), criteria for eligibility (ovarian reserve parameters, age), quality of oocytes and number of oocytes necessary to give at least one live birth.
We propose a monocentric observational cohort study, evaluating the efficacy of oocytes cryopreservation as fertility preservation procedure, in young adult female subjects with endometriosis, to finally define the criteria of eligibility for PF procedures in case of endometriosis.
Detailed Description
Monocentric observational cohort study, enrolling young patients with endometriosis, without birth project for the moment, and asking for fertility preservation, in order to preserve mature oocytes. Protocol of this study : * information and signatures of consent file ; * ovarian stimulation, oocytes retrieval and mature oocytes cryopreservation (one or more procedures) * questionnaires every year, describing quality of life in this context of endometriosis and evolution (treatment, surgery, ART, pregnancies) * data about number and rate of thawed oocytes after preservation, pregnancy rate and live birth rate with these oocytes.
Investigators
Eligibility Criteria
Inclusion Criteria
- •women from 18 to 36 years old
- •endometriosis disease proved by sonography, MRI and/or surgery
- •Consenting to participate to the study
Exclusion Criteria
- •Any contraindication for ovarian stimulation.
- •Any contraindication for pregnancy .- Impossible Follow-up.
Outcomes
Primary Outcomes
characteristics of patients who will benefit from preservation fertility in case of endometriosis (age, parameters of ovarian reserve, endometriosis stage and lesions, previous treatment or surgeries, previous fertility treatment)
Time Frame: 5 years
baseline data
Secondary Outcomes
- Events between fertility preservation and re-use or end of the study 5(5 years)
- rate of patients who will re-use their cryopreserved oocytes(5 years)
- oocytes survival rate(5 years)
- live birth rate(5 years)
- Events between fertility preservation and re-use or end of the study 1(5 years)
- Quality of life, during and after preservation fertility procedure assessed by SF-36 questionnaire(5 years)
- Events between fertility preservation and re-use or end of the study 2(5 years)
- Events between fertility preservation and re-use or end of the study 3(5 years)
- Events between fertility preservation and re-use or end of the study 4(5 years)
- pregnancy rate(5 years)
- birth rate(5 years)