NCT03045315

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 7, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

February 9, 2017

Status Verified

February 1, 2017

Enrollment Period

4.3 years

First QC Date

January 27, 2017

Last Update Submit

February 7, 2017

Conditions

Female Infertility

Outcome Measures

Primary Outcomes (1)

  • Expression of RNAs of LXR pathways in granulosa cells surrounding oocyte

    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 Outcomes (1)

  • Accumulation of lipid in granulosa cells surrounding oocyte

    at day 5

Study Arms (1)

women included in a IVF program

EXPERIMENTAL
Other: IVF Procedure

Interventions

IVF ProcedureOTHER
women included in a IVF program

Eligibility Criteria

Age18 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • dysovulation
  • male infertility
  • Ovarian insuficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

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

Study Officials

  • Florence BRUGNON

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2017

First Posted

February 7, 2017

Study Start

January 1, 2015

Primary Completion

May 1, 2019

Study Completion

August 1, 2019

Last Updated

February 9, 2017

Record last verified: 2017-02

Locations

FR(1)