Use of Metabolomics for the Identification of Endometrial Biomarkers for IRPL and RIF After in Vitro Fertilization (ENDOMETAB)

September 28, 2018 updated by: University Hospital, Angers

Use of Metabolomics for the Identification of Endometrial Biomarkers for Recurrent Pregnancy Loss and Reccurent Implantation Failure Following in Vitro Fertilization.

It is a case-control study composed of 3 groups : 2 cases groups (RIF and IRPL) already composed as part of a pre-existing research project and 1 control group including patients undergoing ART for male factor infertility.

The purpose of this study is to compare the 2 case group with the control group to identify metabolomics signatures.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators have designed a unicentric, case-control, retro- and prospective study to compare the endometrial metabolomics profile in three groups of patients. The two case groups (RIF and IRPL) are already composed and the endometrial and blood samples already taken as part of a pre-existing research project. The current protocol concerns the control group that includes patients undergoing ART for male factor infertility.

The study will include three groups. The first group is composed of patients with a history of RIF following IVF-ET. RIF is defined as failure to obtain a clinical pregnancy (fetal cardiac activity at 6-7 weeks gestational age (GA)) following at least 3 different transfers of at least 4 good quality embryos (fresh or frozen).

The second group comprises patients with a history of IRPL, defined as three or more consecutive pregnancy losses that occurred before 14 weeks gestational age. Early pregnancy losses diagnosed before ultrasonographic confirmation will be included.

The third group will include patients undergoing ART for male factor infertility.

The study protocol will be presented and explained to all eligible patients in the control group during the routine consultation before treatment. Patients who agree to participate will contact the department to program the inclusion visit with one of the attending physicians in the department, during which the blood and endometrial samples will be taken. The inclusion visit will take place at the department of reproductive medicine of Angers University Hospital around day 21 of the menstrual cycle (in the middle of the implantation window, which occurs between day 19 and 23 of the cycle, day 1 being the first menstruation day).

The metabolomics analysis will be performed according to the same protocol for all samples (study and control groups)

Study Type

Interventional

Enrollment (Anticipated)

40

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 Contact

Study Locations

  • France
    • Maine Et Loire
      • Angers, Maine Et Loire, France, 49000
        • Angers University Hospital

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 39 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age between 18 (included) and 40 years (excluded).
  • Patients who agreed to participate and signed the consent form
  • Patients undergoing ART for male factor infertility: male partner with severe oligoasthenospermia or azoospermia.
  • Patients without any prior history of infertility or risk factors for infertility other than the male factor.
  • Patients with a normal basic infertility workup prior to ART (Day 3 serum FSH, LH, Estradiol and AMH; Antral follicle count; hysterosonography or hysterosalpingography)

Exclusion Criteria:

  • Non-French speaking patients.

  • Major patients that are wards of the nation.

    • Patients deprived of their liberty on criminal charges or for civil reasons.
    • Patients under psychiatric care.
    • Patients under legal protection.
    • Patients unable to sign consent forms.
  • Patients not covered by social security (which covers all treatments administered).
  • Patients currently participating in other interventional research projects.

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: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Case group RIF
blood samples, analyzing endometrial cells
Other: metabolomics analysis
collect blood samples and endometrial cells
EXPERIMENTAL: Case group IRPL
blood samples, analyzing endometrial cells
Other: metabolomics analysis
collect blood samples and endometrial cells
ACTIVE_COMPARATOR: Control group
blood samples, analyzing endometrial cells
Other: metabolomics analysis
collect blood samples and endometrial cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analyze the endometrial samples with mass spectrometry using the Biocrates kit (measures 188 metabolites)
Time Frame: 1 day
To compare the metabolomics profile of the endometrium in patients with RIF or IRPL following IVF-ET to patients undergoing Assisted Reproductive Technologies (ART) for male factor infertility to see if there is any significant difference, qualitative or quantitative or both in the metabolites.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analyze the blood sample with standard biological examination and the endometrial sample with mass spectrometry using the Biocrates kit
Time Frame: 1 day
To compare the metabolomics profiles based on endometrial cells to profiles based on blood samples, and to compare the profiles between the 2 groups (RIF and IRPL). If any difference, analyze the mecanisms behind it.
1 day
Analyze the endometrial samples with mass spectrometry using the Biocrates kit
Time Frame: 1 day
To analyze the endometrial metabolomics profile according to the etiology of infertility in the group of patients with RIF following IVF-ET (endometriosis, low ovarian reserve, polycystic ovarian syndrome…).
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

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 (ANTICIPATED)

January 1, 2019

Primary Completion (ANTICIPATED)

January 1, 2021

Study Completion (ANTICIPATED)

January 1, 2021

Study Registration Dates

First Submitted

September 17, 2018

First Submitted That Met QC Criteria

September 28, 2018

First Posted (ACTUAL)

October 1, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 1, 2018

Last Update Submitted That Met QC Criteria

September 28, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCB n°2018-A01871-54

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Recurrent Implantation Failure

Clinical Trials on metabolomics analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ukraine

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe