Endometriosis
Conditions
Keywords
Fertility Preservation, Endometriosis, Endometriomas, Ovarian stimulation, Oocyte vitrification
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.
Interventions
None listed
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 36 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 5 years | baseline data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| oocytes survival rate | 5 years | follow up data |
| pregnancy rate | 5 years | follow up data |
| birth rate | 5 years | follow up data |
| live birth rate | 5 years | follow up data |
| Quality of life, during and after preservation fertility procedure assessed by SF-36 questionnaire | 5 years | Patients complete a SF-36 questionnaire |
| rate of patients who will re-use their cryopreserved oocytes | 5 years | follow up data |
| Events between fertility preservation and re-use or end of the study 2 | 5 years | Number of surgical procedures for endometriosis during the year |
| Events between fertility preservation and re-use or end of the study 3 | 5 years | Pregnancy during the year (and type of pregnancy: abortion, clinical pregnancy, delivery) |
| Events between fertility preservation and re-use or end of the study 4 | 5 years | Duration of medical treatement for endometriosis during the year: number of months during the year |
| Events between fertility preservation and re-use or end of the study 5 | 5 years | Type of medical treatement for endometriosis during the year: class of molecule |
| Events between fertility preservation and re-use or end of the study 1 | 5 years | Nature of surgical procedures for endometriosis during the year |
Countries
France
Contacts
Primary ContactEmmanuelle Mathieu d'Argent, MD
Backup ContactEmile Darai, MD, PhD
Outcome results
None listed