Clinical trial NCT03744754: Fertility Preservation in Case of Endometriosis
Official title: Fertility Preservation in Case of Endometriosis : Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometriosis
Keywords: Fertility Preservation
Endometriosis
Endometriomas
Ovarian stimulation
Oocyte vitrification
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 36
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from endometriosis, referred to our tertiary care university hospital for fertility preservation, from 18 to 36 years old.

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.

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.

Primary outcomes:
measure: 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)
timeFrame: 5 years
Secondary outcomes:
measure: rate of patients who will re-use their cryopreserved oocytes
timeFrame: 5 years
measure: oocytes survival rate
timeFrame: 5 years
measure: pregnancy rate
timeFrame: 5 years
measure: birth rate
timeFrame: 5 years
measure: live birth rate
timeFrame: 5 years
measure: Quality of life, during and after preservation fertility procedure assessed by SF-36 questionnaire
timeFrame: 5 years
measure: Events between fertility preservation and re-use or end of the study 1
timeFrame: 5 years
measure: Events between fertility preservation and re-use or end of the study 2
timeFrame: 5 years
measure: Events between fertility preservation and re-use or end of the study 3
timeFrame: 5 years
measure: Events between fertility preservation and re-use or end of the study 4
timeFrame: 5 years
measure: Events between fertility preservation and re-use or end of the study 5
timeFrame: 5 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Gynécologie Obstétrique et Médecine de la Reproduction Hôpital TENON
state: Ile De France
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Emmanuelle Mathieu d'Argent, MD
role: PRINCIPAL_INVESTIGATOR
References: