Fertility Preservation in Case of Endometriosis
- Conditions
- Endometriosis
- Registration Number
- NCT03744754
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 100
- women from 18 to 36 years old
- endometriosis disease proved by sonography, MRI and/or surgery
- Consenting to participate to the study
- Any contraindication for ovarian stimulation.
- Any contraindication for pregnancy .- Impossible Follow-up.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
rate of patients who will re-use their cryopreserved oocytes 5 years follow up data
oocytes survival rate 5 years follow up data
live birth rate 5 years follow up data
Events between fertility preservation and re-use or end of the study 1 5 years Nature of surgical procedures for endometriosis during the year
Quality of life, during and after preservation fertility procedure assessed by SF-36 questionnaire 5 years Patients complete a SF-36 questionnaire
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
pregnancy rate 5 years follow up data
birth rate 5 years follow up data
Trial Locations
- Locations (1)
Service de Gynécologie Obstétrique et Médecine de la Reproduction Hôpital TENON
🇫🇷Paris, Ile De France, France