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

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ClinicalTrials.gov Identifier: NCT03690830
Recruitment Status : Unknown
Verified September 2018 by University Hospital, Angers.
Recruitment status was:  Not yet recruiting
First Posted : October 1, 2018
Last Update Posted : October 1, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Recurrent Pregnancy Loss Recurrent Implantation Failure Other: metabolomics analysis Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two case groups (Recurrent Implantation Failure and idiopathic recurrent pregnancy loss ) One control group (patients undergoing Assisted ReproductiveTechnologies (ART) for male factor infertility)
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Use of Metabolomics for the Identification of Endometrial Biomarkers for Recurrent Pregnancy Loss and Reccurent Implantation Failure Following in Vitro Fertilization.
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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…).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   women pregnancy
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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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): NCT03690830


Contacts
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Contact: Pierre-Emmanuel BOUET, MD +33(0)241354213 PierreEmmanuel.Bouet@chu-angers.fr

Locations
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France
Angers University hospital
Angers, Maine Et Loire, France, 49000
Sponsors and Collaborators
University Hospital, Angers
More Information
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT03690830    
Other Study ID Numbers: RCB n°2018-A01871-54
First Posted: October 1, 2018    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Angers:
Metabolomic
Endometrial biomarkers
Infertility
Additional relevant MeSH terms:
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Abortion, Habitual
Abortion, Spontaneous
Pregnancy Complications