Endometriosis Impact on Oocyte Quality

Endometriosis Clinical Trial

— EndOvo  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03241329
• Other study ID #: 2017-A01163-50
• Status: Recruiting
• Start date: February 26, 2018
• Est. completion date: November 12, 2021

Study information

• Verified date: July 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Khaled POCATE-CHERIET, MD, PhD
• Phone: +33 1 58 41 37 00
• Email: khaled.pocate[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: November 12, 2021
• Est. primary completion date: November 12, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Locations

Country	Name	City	State
France	Hôpital Cochin-Port Royal	Paris

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