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LXR and Oocyte Meiosis Resumption

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ClinicalTrials.gov Identifier: NCT03045315
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : February 9, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:
Previous studies in animal model showed clearly that lipid homeostasis influence oocyte meiosis resumption. However Liver X Receptors pathway has never been investigated in human ovocyte

Condition or disease Intervention/treatment Phase
Female Infertility Other: IVF Procedure Not Applicable

Detailed Description:
In mice deficient of Liver X Receptor (LXR) genes, the oocytes are unable to resume meiosis. Oxysterols are molecules derived from the cholesterol synthesis pathway. They are ligands of the liver X receptors (LXRs). In human, the LXR signalling pathway has never been investigated in this process. The Investigator propose to analyse in granulosa cells surrounding ovocyte the expression of LXR, their target genes and the enzymes involved in oxysterols synthesis. These granulosa cells are normally retrieved and destroyed 18 hours after sperm insemination of oocytes in a In Vitro Fertilization program. The oocyte meiosis resumption will be considered as positive (Granulosa cell positive, GC+) if a zygote is observed 18 hours after sperm insemination and negative (Granulosa cell negative, GC-) if none zygote appears. Moreover the investigator will analyse the quality of embryo development during 5 days after zygote is formed (normal process of In Vitro Fertilization) . The both populations of granulosa cells (GC+ and GC-) will be compared. The measurements of Liver X Receptor genes and the enzymes involved in oxysterols pathways xill be performed by Reverse Transcription-Polymerase Chain Reaction. The accumulation of lipid in granulosa cells will be measures by oil red staining. By this sudy the investigator will probably find new biological markers of resumption meiosis for women enrolled in In Vitro Fertilization programm. Moreover, data will help to better understand the physiopathology of oocyte meiosis failures.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
Official Title: Are LXRs Involved in Regulation of Human Oocyte Meiosis Resumption?
Actual Study Start Date : January 2015
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: women included in a IVF program Other: IVF Procedure



Primary Outcome Measures :
  1. Expression of RNAs of LXR pathways in granulosa cells surrounding oocyte [ Time Frame: at day 1 ]
    The day of the retrieve of granulosa cells, RNA extraction will be performed and the expression of Liver X Receptors genes, their downstream target genes and the enzymes of oxyterols synthesis will be analysed.


Secondary Outcome Measures :
  1. Accumulation of lipid in granulosa cells surrounding oocyte [ Time Frame: at day 5 ]
    Embryo development of inseminated ovocytes at day 5 after sperm insemination during In Vitro Fertilization process



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Ages Eligible for Study:   18 Years to 36 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • woman aged less 37 years
  • included in a IVF program
  • tubal infertility
  • ovarian stimulation with recombinant FSH
  • induced ovulation by recombinant chorionic gonaotrophin

Exclusion Criteria:

  • dysovulation
  • male infertility
  • Ovarian insuficiency

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): NCT03045315


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Florence BRUGNON         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Florence BRUGNON University Hospital, Clermont-Ferrand

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03045315     History of Changes
Other Study ID Numbers: CHU-303
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: February 9, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female