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
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 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|
|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|
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
- Metabolic profile [ Time Frame: 2 years ]Identification of a possible particular metabolomic profile from the follicular fluid in endometriosis
- Transcriptomic profile [ Time Frame: 2 years ]Identification of a possible particular transcriptomic profile from the cumulus cells in endometriosis
- 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
- Samples without DNA : follicular fluids
- Samples with DNA : cumulus cells from which RNA will be extracted in order to perform transcriptomics analysis
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
|Contact: Khaled POCATE-CHERIET, MD, PhD||+33 1 58 41 37 email@example.com|
|Contact: Christelle AUGER||+ 33 1 58 41 11 firstname.lastname@example.org|
|Hôpital Cochin-Port Royal||Recruiting|
|Paris, France, 75014|
|Contact: Khaled POCATE-CHERIET, MD, PhD +33 1 58 41 37 27 email@example.com|
|Principal Investigator:||Khaled POCATE-CHERIET, MD, PhD||Assistance Publique - Hôpitaux de Paris|