Fertility Preservation in Case of Endometriosis

NCT03744754 | Unknown

• 1 other identifier: APHP180260
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Keywords

Fertility Preservation; Endometriosis; Endometriomas; Ovarian stimulation; Oocyte vitrification

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• rate of patients who will re-use their cryopreserved oocytes

  5 years

• oocytes survival rate

  5 years

• pregnancy rate

  5 years

• birth rate

  5 years

• live birth rate

  5 years

Study Arms (1)

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)

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• women from 18 to 36 years old
• endometriosis disease proved by sonography, MRI and/or surgery
• Consenting to participate to the study

You may not qualify if:

• Any contraindication for ovarian stimulation.
• Any contraindication for pregnancy .- Impossible Follow-up.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de Gynécologie Obstétrique et Médecine de la Reproduction Hôpital TENON

Paris, Île-de-France Region, 75020, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples of follicular fluid, blood, endometrial samples

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Emmanuelle Mathieu d'Argent, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuelle Mathieu d'Argent, MD

CONTACT

+33 156 01 68 69; emmanuelle.mathieu@aphp.fr

Emile Darai, MD, PhD

CONTACT

emile.darai@tnn.aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: November 16, 2018
• Study Start: December 4, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2025
• Last Updated: March 5, 2019

Record last verified: 2019-02

Locations

FR (1)