Use of Metabolomics for the Identification of Endometrial Biomarkers for IRPL and RIF After in Vitro Fertilization
NCT ID: NCT03690830
Last Updated: 2018-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2019-01-01
2021-01-01
Brief Summary
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The purpose of this study is to compare the 2 case group with the control group to identify metabolomics signatures.
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Detailed Description
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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)
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Case group RIF
blood samples, analyzing endometrial cells
metabolomics analysis
collect blood samples and endometrial cells
Case group IRPL
blood samples, analyzing endometrial cells
metabolomics analysis
collect blood samples and endometrial cells
Control group
blood samples, analyzing endometrial cells
metabolomics analysis
collect blood samples and endometrial cells
Interventions
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metabolomics analysis
collect blood samples and endometrial cells
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
39 Years
FEMALE
No
Sponsors
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University Hospital, Angers
OTHER_GOV
Responsible Party
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Locations
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Angers University hospital
Angers, Maine Et Loire, France
Countries
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Central Contacts
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Other Identifiers
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RCB n°2018-A01871-54
Identifier Type: -
Identifier Source: org_study_id
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