Impact of Embryo Cryopreservation on Birth Weight

June 19, 2019 updated by: University Hospital, Montpellier

Is Cryopreserved Embryo Replacement is Associated With Higher Birthweight Compared With Fresh Embryo ? Sibling Embryo Cohort Study

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

183

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
      • Montpellier, France, 34295
        • UH Montpellier

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

18 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-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

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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
Frozen embryo transfer
Fresh embryo transfer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
birthweight
Time Frame: 1 day
change after FET than after fresh embryo transfer
1 day

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Margaux Anav, Doctor, University Hospital, Montpellier

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)

May 1, 2007

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 30, 2015

Study Registration Dates

First Submitted

June 14, 2019

First Submitted That Met QC Criteria

June 14, 2019

First Posted (Actual)

June 18, 2019

Study Record Updates

Last Update Posted (Actual)

June 21, 2019

Last Update Submitted That Met QC Criteria

June 19, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL19_0306

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

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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