Ovarian Reserve and Embryo Implantation (IRO)

June 17, 2019 updated by: Centre Hospitalier Universitaire de Nīmes
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".

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

598

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nîmes, France
        • CHUNimes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The population concerned is all young patients, defined as being under 35 years old, who have benefited from IVF in the 2 inclusion centres (Centres d'Aide Médicale à la Procréation des CHU de Nîmes and the Saint Roch clinic in Montpellier) between 01/01/2014 and 30/06/2015.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The embryo implantation rate at 5 weeks after transfer is defined by the presence of an embryo with objective cardiac activity by ultrasound
Time Frame: 5weeks
The embryo implantation rate corresponds to the number of embryos with cardiac activity found on the number of embryos transferred
5weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 29, 2018

Primary Completion (ACTUAL)

April 30, 2019

Study Completion (ACTUAL)

April 30, 2019

Study Registration Dates

First Submitted

June 13, 2019

First Submitted That Met QC Criteria

June 17, 2019

First Posted (ACTUAL)

June 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 18, 2019

Last Update Submitted That Met QC Criteria

June 17, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Local/2018/OP-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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