NCT03690830

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 1, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

October 1, 2018

Status Verified

September 1, 2018

Enrollment Period

2 years

First QC Date

September 17, 2018

Last Update Submit

September 28, 2018

Conditions

Recurrent Pregnancy LossRecurrent Implantation Failure

Keywords

MetabolomicEndometrial biomarkersInfertility

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 day

Secondary Outcomes (2)

  • Analyze the blood sample with standard biological examination and the endometrial sample with mass spectrometry using the Biocrates kit

    1 day

  • Analyze the endometrial samples with mass spectrometry using the Biocrates kit

    1 day

Study Arms (3)

Case group RIF

EXPERIMENTAL

blood samples, analyzing endometrial cells

Other: metabolomics analysis

Case group IRPL

EXPERIMENTAL

blood samples, analyzing endometrial cells

Other: metabolomics analysis

Control group

ACTIVE COMPARATOR

blood samples, analyzing endometrial cells

Other: metabolomics analysis

Interventions

metabolomics analysisOTHER

collect blood samples and endometrial cells

Case group IRPLCase group RIFControl group

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen pregnancy
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angers University hospital

Angers, Maine Et Loire, 49000, France

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Central Study Contacts

Pierre-Emmanuel BOUET, MD

CONTACT

+33(0)241354213PierreEmmanuel.Bouet@chu-angers.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two case groups (Recurrent Implantation Failure and idiopathic recurrent pregnancy loss ) One control group (patients undergoing Assisted ReproductiveTechnologies (ART) for male factor infertility)
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2018

First Posted

October 1, 2018

Study Start

January 1, 2019

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

October 1, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will share

Locations

FR(1)