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Endometriosis Impact on Oocyte Quality (EndOvo)

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ClinicalTrials.gov Identifier: NCT03241329
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
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 trancriptomic 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.


Condition or disease
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
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Characterization of Normal and Pathological Oocyte Cohort After Controlled Ovarian Stimulation: Example of Endometriosis
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

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



Primary Outcome Measures :
  1. Metabolic profile [ Time Frame: 2 years ]
    Identification of a possible particular metabolomic profile from the follicular fluid in endometriosis

  2. Transcriptomic profile [ Time Frame: 2 years ]
    Identification of a possible particular transcriptomic profile from the cumulus cells in endometriosis


Secondary Outcome Measures :
  1. Oocyte characterization [ Time Frame: 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.


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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients enrolled in a ART attempt in the IVF unit of the center.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241329


Contacts
Contact: Khaled POCATE-CHERIET, MD, PhD +33 1 58 41 37 00 khaled.pocate@aphp.fr
Contact: Christelle AUGER + 33 1 58 41 11 86 christelle.auger@aphp.fr

Locations
France
Hôpital Cochin-Port Royal Recruiting
Paris, France, 75014
Contact: Khaled POCATE-CHERIET, MD, PhD    +33 1 58 41 37 27    khaled.pocate@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Khaled POCATE-CHERIET, MD, PhD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03241329     History of Changes
Other Study ID Numbers: 2017-A01163-50
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Endometriosis
Metabolomics
Transcriptomics
Follicular fluid
Cumulus cells
Oocyte quality

Additional relevant MeSH terms:
Endometriosis
Genital Diseases, Female