NCT03989843

Brief Summary

Birth weight (BW) is higher after frozen embryo transfer (FET) than after fresh embryo replacement. No study has compared the BW of siblings conceived using the same oocyte/embryo cohort. The aim of this study was to determine whether the freezing-thawing procedure is involved in such difference.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
183

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2007

Longer than P75 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

May 1, 2007

Completed
8.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2015

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed
Last Updated

June 21, 2019

Status Verified

June 1, 2019

Enrollment Period

8.1 years

First QC Date

June 14, 2019

Last Update Submit

June 19, 2019

Conditions

Infertility

Keywords

ARTBirthweightSiblingsCryopreservationEpigeneticMedical assistance to procreation

Outcome Measures

Primary Outcomes (1)

  • birthweight

    change after FET than after fresh embryo transfer

    1 day

Study Arms (2)

Frozen embryo transfer

Frozen embryo transfer

Fresh embryo transfer

Fresh embryo transfer

Eligibility Criteria

Age18 Years - 43 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

sibling pairs where fresh embryo replacement resulting in a singleton live birth was followed by transfer of one or two frozen embryos from the same cohort that resulted in a singleton live birth, between May 2007 and June 2015. Twin pregnancies and stillbirths were excluded. If the BW of at least one sibling was unknown, the pair was not included in the study

You may qualify if:

  • sibling pairs where fresh embryo replacement resulting in a singleton live birth was followed by transfer of one or two frozen embryos from the same cohort that resulted in a singleton live birth, between May 2007 and June 2015.

You may not qualify if:

  • Twin pregnancies and stillbirths were excluded. If the BW of at least one sibling was unknown, the pair was not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

InfertilityBirth Weight

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Margaux Anav, Doctor

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 14, 2019

First Posted

June 18, 2019

Study Start

May 1, 2007

Primary Completion

June 1, 2015

Study Completion

June 30, 2015

Last Updated

June 21, 2019

Record last verified: 2019-06

Locations

FR(1)