Recurrent Pregnancy LossENDOMETABNCT03690830
Use of Metabolomics for the Identification of Endometrial Biomarkers for IRPL and RIF After in Vitro Fertilization
A study testing metabolomics analysis in people with Recurrent Pregnancy Loss and Recurrent Implantation Failure, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Recurrent Pregnancy Loss, Recurrent Implantation Failure
- What is being tested?
- metabolomics analysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2019to 1 Jan 2021
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Being tested
- metabolomics analysis
- Keywords
- Metabolomic, Endometrial biomarkers, Infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
metabolomics analysisOther
collect blood samples and endometrial cells
| Study group | Role | What they receive |
|---|---|---|
| Case group RIF | Experimental | blood samples, analyzing endometrial cells Receives: Other: metabolomics analysis |
| Case group IRPL | Experimental | blood samples, analyzing endometrial cells Receives: Other: metabolomics analysis |
| Control group | Active comparator | blood samples, analyzing endometrial cells Receives: Other: metabolomics analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (2)
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.
Measured: 1 day
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…).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start1 Jan 2019 (estimated)
- Primary completion1 Jan 2021 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Pregnancy LossStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690830
- Sponsor's protocol ID
- RCB n°2018-A01871-54
- Acronym
- ENDOMETAB
- Status last verified
- Sep 2018
- First submitted
- 17 Sep 2018
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Metabolomics for the Identification of Endometrial Biomarkers for Recurrent Pregnancy Loss and Reccurent Implantation Failure Following in Vitro Fertilization.
- ClinicalTrials.gov ID
- NCT03690830
- Acronym / sponsor ID
- ENDOMETAB / RCB n°2018-A01871-54
- Keywords
- Metabolomic, Endometrial biomarkers, Infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 1 Jan 2021 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 1 Oct 2018 (actual)
- 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.
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)
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| Case group RIF | Experimental | Other: metabolomics analysisblood samples, analyzing endometrial cells |
| Case group IRPL | Experimental | Other: metabolomics analysisblood samples, analyzing endometrial cells |
| Control group | Active comparator | Other: metabolomics analysisblood samples, analyzing endometrial cells |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (8 listed)
- Non-French speaking patients.
- Major patients that are wards of the nation.
- Patients not covered by social security (which covers all treatments administered).
- Patients currently participating in other interventional research projects.
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 |
|---|---|---|
| metabolomics analysiscollect blood samples and endometrial cells | Other | Case group IRPL, Case group RIF, Control group |
Primary outcome
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.
2 secondary outcomes
Analyze the blood sample with standard biological examination and the endometrial sample with mass spectrometry using the Biocrates kit
Time frame: 1 day
Analyze the endometrial samples with mass spectrometry using the Biocrates kit
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing metabolomics analysis in people with Recurrent Pregnancy Loss and Recurrent Implantation Failure, run by University Hospital, Angers 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 8 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 1 Oct 2018. 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 Pierre-Emmanuel BOUET, MD (+33(0)241354213, PierreEmmanuel.Bouet@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyze the endometrial samples with mass spectrometry using the Biocrates kit (measures 188 metabolites) (time frame: 1 day). 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 1 Oct 2018.