Endometriosis Impact on Oocyte Quality (EndOvo)

Characterization of Normal and Pathological Oocyte Cohort After Controlled Ovarian Stimulation: Example of Endometriosis

The aim of this study is to evaluate the impact of endometriosis on folliculogenesis and oocyte quality. To do so, a metabolomic approach will be conducted in order to analyze the follicular fluid. This evaluation will be completed by a transcriptomic analysis from the cumulus cells of the oocyte.

The normal and pathological oocyte cohort after controlled ovarian stimulation will be also characterized by identifying the oocyte leading to live birth.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis

Detailed Description

Endometriosis pathophysiology remains under controversy. Among the various issues raised, that of his involvement in an implantation failure related to an alteration of the endometrium is advanced by some authors. For others, infertility would be linked to an alteration of the oocyte quality responsible for embryonic development impairment leading to a lack of implantation. Several research groups have also mentioned the association of the two mechanisms.

The oocyte quality evaluation is also subject to controversy. Indeed, its morphological approach remains the most commonly used in routine at the IVF laboratory. However, this tool remains limited and to date, no correlation between oocyte morphology and ART outcomes have been established. In this context, there is a real need to use functional approaches such as genomics, transcriptomics, proteomics and metabolomics. However, the clinical validation and application of these functional tools have to be evaluated from a human pathology model such as endometriosis.

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

Contacts and Locations

• Study Contact: Name: Khaled POCATE-CHERIET, MD, PhD; Phone Number: +33 1 58 41 37 00; Email: khaled.pocate@aphp.fr
• Study Contact Backup: Name: Marie BENHAMMANI-GODARD; Phone Number: +33 1 58 41 11 90; Email: marie.godard@aphp.fr

Study Locations

• France
  • Paris, France, 75014
    • Recruiting
    • Hôpital Cochin-Port Royal
    • Contact: Khaled POCATE-CHERIET, MD, PhD; Phone Number: +33 1 58 41 37 27; Email: khaled.pocate@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

patients enrolled in a ART (assisted reproductive technology) attempt in the IVF unit of the center.

Description

Inclusion Criteria:

Group 1: case

a. Womens with endometriosis i. Deep endometriosis without ovarian localisation ii. Deep endometriosis associated with ovarian localisation iii. Isolated ovarian localisation b. Male partner with normal sperm parameters Group 2 : control

1. Womens with isolated tubal factor
2. Male partner with normal sperm parameters

Exclusion Criteria:

• Other pathologies responsible for female infertility
• Altered sperm parameters
• Male or female viral risk
• Oocyte or sperm donation

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Case : endometriosis; Infertile patients with endometriosis that is the only cause of their infertility
Control : tubal factor; infertile patients with tubal factor that is the only cause of their infertility

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic profile	Identification of a possible particular metabolomic profile from the follicular fluid in endometriosis	2 years
Transcriptomic profile	Identification of a possible particular transcriptomic profile from the cumulus cells in endometriosis	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oocyte characterization	Identification of a possible transcriptomic profile from the cumulus cells of the oocyte which could be predictive of live birth. Search of correlations between these profiles and (i) oocyte and embryo morphology and (ii) clinical and neonatal outcomes after embryo transfer.	2 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Khaled POCATE-CHERIET, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2018
• Primary Completion (Anticipated): November 12, 2021
• Study Completion (Anticipated): November 12, 2021

Study Registration Dates

• First Submitted: August 2, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Metabolomics; Endometriosis; Transcriptomics; Follicular fluid; Cumulus cells; Oocyte quality
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: 2017-A01163-50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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