NCT03989921

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".

Trial Health

87
On Track

Trial Health Score

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

Enrollment
598

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 29, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 13, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

5 months

First QC Date

June 13, 2019

Last Update Submit

June 17, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

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

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

    5weeks

Study Arms (2)

normo responders

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

Other: no intervention. observational study

poor responders

with a dosage of less than 1.2 ng/mL

Other: no intervention. observational study

Interventions

no intervention. observational study

normo responderspoor responders

Eligibility Criteria

Age35 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUNimes

Nîmes, France

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2019

First Posted

June 18, 2019

Study Start

November 29, 2018

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

June 18, 2019

Record last verified: 2019-06

Locations