Use of Metabolomics for the Identification of Endometrial Biomarkers for IRPL and RIF After in Vitro Fertilization (ENDOMETAB)
Primary Purpose
Recurrent Pregnancy Loss, Recurrent Implantation Failure
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
metabolomics analysis
Sponsored by
About this trial
This is an interventional other trial for Recurrent Pregnancy Loss focused on measuring Metabolomic, Endometrial biomarkers, Infertility
Eligibility 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.
Sites / Locations
- Angers University hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Case group RIF
Case group IRPL
Control group
Arm Description
blood samples, analyzing endometrial cells
blood samples, analyzing endometrial cells
blood samples, analyzing endometrial cells
Outcomes
Primary Outcome Measures
Analyze the endometrial samples with mass spectrometry using the Biocrates kit (measures 188 metabolites)
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
Analyze the blood sample with standard biological examination and the endometrial sample with mass spectrometry using the Biocrates kit
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.
Analyze the endometrial samples with mass spectrometry using the Biocrates kit
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…).
Full Information
NCT ID
NCT03690830
First Posted
September 17, 2018
Last Updated
September 28, 2018
Sponsor
University Hospital, Angers
1. Study Identification
Unique Protocol Identification Number
NCT03690830
Brief Title
Use of Metabolomics for the Identification of Endometrial Biomarkers for IRPL and RIF After in Vitro Fertilization
Acronym
ENDOMETAB
Official Title
Use of Metabolomics for the Identification of Endometrial Biomarkers for Recurrent Pregnancy Loss and Reccurent Implantation Failure Following in Vitro Fertilization.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2019 (Anticipated)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
January 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Pregnancy Loss, Recurrent Implantation Failure
Keywords
Metabolomic, Endometrial biomarkers, Infertility
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Case group RIF
Arm Type
Experimental
Arm Description
blood samples, analyzing endometrial cells
Arm Title
Case group IRPL
Arm Type
Experimental
Arm Description
blood samples, analyzing endometrial cells
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
blood samples, analyzing endometrial cells
Intervention Type
Other
Intervention Name(s)
metabolomics analysis
Intervention Description
collect blood samples and endometrial cells
Primary Outcome Measure Information:
Title
Analyze the endometrial samples with mass spectrometry using the Biocrates kit (measures 188 metabolites)
Description
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.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Analyze the blood sample with standard biological examination and the endometrial sample with mass spectrometry using the Biocrates kit
Description
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.
Time Frame
1 day
Title
Analyze the endometrial samples with mass spectrometry using the Biocrates kit
Description
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…).
Time Frame
1 day
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
women pregnancy
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre-Emmanuel BOUET, MD
Phone
+33(0)241354213
Email
PierreEmmanuel.Bouet@chu-angers.fr
Facility Information:
Facility Name
Angers University hospital
City
Angers
State/Province
Maine Et Loire
ZIP/Postal Code
49000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Use of Metabolomics for the Identification of Endometrial Biomarkers for IRPL and RIF After in Vitro Fertilization
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