Fertility Preservation in Case of Endometriosis

NCT ID: NCT03744754

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-12-04
• Study Completion Date: 2025-12-31

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.

Conditions

Endometriosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Women with endometriosis

Women with endometriosis disease aged 18-36 years, with appropriate endometriosis diagnosis, based on transvaginal sonography, magnetic resonance imaging and/or previous surgery.Ovarian reserve was assessed by antral follicle counting (AFC) and measurement of serum anti-Mullerian hormone (AMH) levels Enrolled after preservation fertility procedure (vitrification of mature oocytes)

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 36 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emmanuelle Mathieu d'Argent, MD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Service de Gynécologie Obstétrique et Médecine de la Reproduction Hôpital TENON

Paris, Île-de-France Region, France

Site Status: RECRUITING

Countries

France

Central Contacts

Emmanuelle Mathieu d'Argent, MD

Role: CONTACT

emmanuelle.mathieu@aphp.fr

+33 156 01 68 69

Emile Darai, MD, PhD

Role: CONTACT

emile.darai@tnn.aphp.fr

Facility Contacts

Emmanuelle Mathieu d'Argent, MD

Role: primary

emmadargent@gmail.com

+33 156 01 68 69

Other Identifiers

APHP180260

Identifier Type: -

Identifier Source: org_study_id