Female InfertilityNCT03045315
LXR and Oocyte Meiosis Resumption
A study testing IVF Procedure in people with Female Infertility, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- Female Infertility
- What is being tested?
- IVF Procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- woman aged less 37 years
- included in a IVF program
- tubal infertility
- ovarian stimulation with recombinant FSH
- induced ovulation by recombinant chorionic gonaotrophin
Who cannot join
- dysovulation
- male infertility
- Ovarian insuficiency
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 04 73 75 11 95, placarin@chu-clermontferrand.fr
Florence BRUGNON
About this study
Official title: 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
Read the 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.
- Conditions
- Female Infertility
- Being tested
- IVF Procedure
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVF ProcedureOther
| Study group | Role | What they receive |
|---|---|---|
| women included in a IVF program | Experimental | Not described Receives: Other: IVF Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at day 1
Secondary outcomes (1)
Accumulation of lipid in granulosa cells surrounding oocyte
Embryo development of inseminated ovocytes at day 5 after sperm insemination during In Vitro Fertilization process
Measured: at day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2017 (estimated)
- Study startJan 2015
- Primary completionMay 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female InfertilityStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence BRUGNON, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03045315
- Sponsor's protocol ID
- CHU-303
- Status last verified
- Feb 2017
- First submitted
- 27 Jan 2017
- Last updated
- 9 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are LXRs Involved in Regulation of Human Oocyte Meiosis Resumption?
- ClinicalTrials.gov ID
- NCT03045315
- Acronym / sponsor ID
- CHU-303
- Conditions
- Female Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 7 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women included in a IVF program | Experimental | Other: IVF Procedure |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- woman aged less 37 years
- included in a IVF program
- tubal infertility
- ovarian stimulation with recombinant FSH
- induced ovulation by recombinant chorionic gonaotrophin
Key exclusion criteria (3 listed)
- dysovulation
- male infertility
- Ovarian insuficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVF Procedure | Other | women included in a IVF program |
Primary outcome
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.
1 secondary outcome
Accumulation of lipid in granulosa cells surrounding oocyte
Time frame: at day 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence BRUGNON principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IVF Procedure in people with Female Infertility, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (04 73 75 11 95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of RNAs of LXR pathways in granulosa cells surrounding oocyte (time frame: at day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2017; AzTrials last refreshed its copy on 7 Nov 2026.