Clinical trial NCT03241329: Endometriosis Impact on Oocyte Quality
Official title: Characterization of Normal and Pathological Oocyte Cohort After Controlled Ovarian Stimulation: Example of Endometriosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endometriosis
Keywords: Endometriosis
Metabolomics
Transcriptomics
Follicular fluid
Cumulus cells
Oocyte quality
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients enrolled in a ART (assisted reproductive technology) attempt in the IVF unit of the center.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Metabolic profile
timeFrame: 2 years
measure: Transcriptomic profile
timeFrame: 2 years
Secondary outcomes:
measure: Oocyte characterization
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Cochin-Port Royal
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Khaled POCATE-CHERIET, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: