Fertility Preservation in Case of Endometriosis (PREFENDO)

Fertility Preservation in Case of Endometriosis : Observational Cohort Study

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.

Study Overview

• Status: Recruiting
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Emmanuelle Mathieu d'Argent, MD; Phone Number: +33 156 01 68 69; Email: emmanuelle.mathieu@aphp.fr
• Study Contact Backup: Name: Emile Darai, MD, PhD; Email: emile.darai@tnn.aphp.fr

Study Locations

• France
  • Ile De France
    • Paris, Ile De France, France, 75020
      • Recruiting
      • Service de Gynécologie Obstétrique et Médecine de la Reproduction Hôpital TENON
      • Contact: Emmanuelle Mathieu d'Argent, MD; Phone Number: +33 156 01 68 69; Email: emmadargent@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	baseline data	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of patients who will re-use their cryopreserved oocytes	follow up data	5 years
oocytes survival rate	follow up data	5 years
pregnancy rate	follow up data	5 years
birth rate	follow up data	5 years
live birth rate	follow up data	5 years
Quality of life, during and after preservation fertility procedure assessed by SF-36 questionnaire	Patients complete a SF-36 questionnaire	5 years
Events between fertility preservation and re-use or end of the study 1	Nature of surgical procedures for endometriosis during the year	5 years
Events between fertility preservation and re-use or end of the study 2	Number of surgical procedures for endometriosis during the year	5 years
Events between fertility preservation and re-use or end of the study 3	Pregnancy during the year (and type of pregnancy: abortion, clinical pregnancy, delivery)	5 years
Events between fertility preservation and re-use or end of the study 4	Duration of medical treatement for endometriosis during the year: number of months during the year	5 years
Events between fertility preservation and re-use or end of the study 5	Type of medical treatement for endometriosis during the year: class of molecule	5 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Emmanuelle Mathieu d'Argent, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: October 10, 2018
• First Submitted That Met QC Criteria: November 14, 2018
• First Posted (Actual): November 16, 2018

Study Record Updates

• Last Update Posted (Actual): March 5, 2019
• Last Update Submitted That Met QC Criteria: March 1, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Endometriosis; Ovarian stimulation; Fertility Preservation; Oocyte vitrification; Endometriomas
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: APHP180260

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No