NCT03241329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

February 26, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2018

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

August 2, 2017

Last Update Submit

September 5, 2025

Conditions

Keywords

EndometriosisMetabolomicsTranscriptomicsFollicular fluidCumulus cellsOocyte quality

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Oocyte characterization

    2 years

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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
  • Womens with isolated tubal factor
  • Male partner with normal sperm parameters

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Cochin-Port Royal

Paris, Paris, 75014, France

Location

Related Publications (1)

  • Pocate-Cheriet K, Santulli P, Kateb F, Bourdon M, Maignien C, Batteux F, Chouzenoux S, Patrat C, Wolf JP, Bertho G, Chapron C. The follicular fluid metabolome differs according to the endometriosis phenotype. Reprod Biomed Online. 2020 Dec;41(6):1023-1037. doi: 10.1016/j.rbmo.2020.09.002. Epub 2020 Sep 4.

    PMID: 33046374BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

1. Samples without DNA : follicular fluids 2. Samples with DNA : cumulus cells from which RNA will be extracted in order to perform transcriptomics analysis

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Khaled POCATE-CHERIET, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2017

First Posted

August 7, 2017

Study Start

February 26, 2018

Primary Completion

July 12, 2018

Study Completion

July 12, 2018

Last Updated

September 11, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations