Endometriosis Impact on Oocyte Quality

• Conditions: Endometriosis

• Registration Number: NCT03241329
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

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 Timeline

• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-02
• Study First Posted: 2017-08-07
• Study Start: 2018-02-26
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-12
• Last Update Posted: 2021-07-14
• Primary Completion: 2021-11-12
• Study Completion: 2021-11-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metabolic profile	2 years	Identification of a possible particular metabolomic profile from the follicular fluid in endometriosis
Transcriptomic profile	2 years	Identification of a possible particular transcriptomic profile from the cumulus cells in endometriosis

Secondary Outcome Measures

Name	Time	Method
Oocyte characterization	2 years	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.

Trial Locations

Locations (1)

Hôpital Cochin-Port Royal; 🇫🇷 Paris, France