Fertility Preservation in Case of Endometriosis

Endometriosis Clinical Trial

— PREFENDO  

Official title:

Fertility Preservation in Case of Endometriosis : Observational Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03744754
• Other study ID #: APHP180260
• Status: Recruiting
• Start date: December 4, 2018
• Est. completion date: December 2025

Study information

• Verified date: February 2019
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Emmanuelle Mathieu d'Argent, MD
• Phone: +33 156 01 68 69
• Email: emmanuelle.mathieu[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
France	Service de Gynécologie Obstétrique et Médecine de la Reproduction Hôpital TENON	Paris	Ile De France

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	rate of patients who will re-use their cryopreserved oocytes	follow up data	5 years
Secondary	oocytes survival rate	follow up data	5 years
Secondary	pregnancy rate	follow up data	5 years
Secondary	birth rate	follow up data	5 years
Secondary	live birth rate	follow up data	5 years
Secondary	Quality of life, during and after preservation fertility procedure assessed by SF-36 questionnaire	Patients complete a SF-36 questionnaire	5 years
Secondary	Events between fertility preservation and re-use or end of the study 1	Nature of surgical procedures for endometriosis during the year	5 years
Secondary	Events between fertility preservation and re-use or end of the study 2	Number of surgical procedures for endometriosis during the year	5 years
Secondary	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
Secondary	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
Secondary	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