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IRO: Ovarian Reserve and Embryo Implantation

Sponsor
Centre Hospitalier Universitaire de Nīmes (Other)
Overall Status
Completed
CT.gov ID
NCT03989921
Collaborator
(none)
598
Enrollment
1
Location
5
Actual Duration (Months)
119.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Compare, in young patients with In vitro fertilization (IVF), the rate of embryo implantation by early culture transfer (J2-J3) between 2 groups of patients: "normo responders" vs. "poor responders".

Condition or Disease Intervention/Treatment Phase
  • Other: no intervention. observational study

Study Design

Study Type:
Observational
Actual Enrollment :
598 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
Ovarian Reserve and Embryo Implantation
Actual Study Start Date :
Nov 29, 2018
Actual Primary Completion Date :
Apr 30, 2019
Actual Study Completion Date :
Apr 30, 2019

Arms and Interventions

Arm Intervention/Treatment
normo responders

that have an AMH dosage greater than or equal to 1.2 ng/mL

Other: no intervention. observational study
no intervention. observational study
poor responders

with a dosage of less than 1.2 ng/mL

Other: no intervention. observational study
no intervention. observational study

Outcome Measures

Primary Outcome Measures

  1. The embryo implantation rate at 5 weeks after transfer is defined by the presence of an embryo with objective cardiac activity by ultrasound [5weeks]

    The embryo implantation rate corresponds to the number of embryos with cardiac activity found on the number of embryos transferred

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • IVF patient managed with or without ICSI between 01/01/2014 and 30/06/2015 in one of the two study centres

  • Age < 35 years old

  • Fresh transfer of at least one embryo between D2 and D6

  • patients who have already received one or more transfer attempts.

Exclusion Criteria:

  • No fresh transfer (Freeze All, segmentation failure, stimulation failure)

  • Double successive embryo transfer (e. g. J3-J5). We did not retain these cases because if only one of the 2 embryos is implanted, it is not possible to know which transfer it corresponds to.

  • Maternal serum FSH determination < 4 IU/ml at D3 in the baseline balance sheet (hypogonadotropic hypogonadism)

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHUNimes Nîmes France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT03989921
Other Study ID Numbers:
  • Local/2018/OP-01
First Posted:
Jun 18, 2019
Last Update Posted:
Jun 18, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 18, 2019