- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03045315
LXR and Oocyte Meiosis Resumption
February 7, 2017 updated by: University Hospital, Clermont-Ferrand
Are LXRs Involved in Regulation of Human Oocyte Meiosis Resumption?
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
Study Overview
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
Enrollment (Anticipated)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Clermont-Ferrand, France, 63003
- Recruiting
- Chu Clermont-Ferrand
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 36 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: women included in a IVF program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
at day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
at day 5
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Anticipated)
May 1, 2019
Study Completion (Anticipated)
August 1, 2019
Study Registration Dates
First Submitted
January 27, 2017
First Submitted That Met QC Criteria
February 3, 2017
First Posted (Estimate)
February 7, 2017
Study Record Updates
Last Update Posted (Estimate)
February 9, 2017
Last Update Submitted That Met QC Criteria
February 7, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-303
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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