Impact of Embryo Cryopreservation on Birth Weight | NCT03989843

Studies
Impact of Embryo Cryopreservation on Birth Weight

NCT03989843

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Jun 21, 2019Actual

Enrollment

183Actual

Phase

Not provided

Conditions

Infertility

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2007Actual

Primary Completion Date

Jun 1, 2015Actual

Completion Date

Jun 30, 2015Actual

First Submitted Date

Jun 14, 2019

First Submission Date that Met QC Criteria

Jun 14, 2019

First Posted Date

Jun 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2019

Last Update Posted Date

Jun 21, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

183Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Frozen embryo transfer		Frozen embryo transfer
Fresh embryo transfer		Fresh embryo transfer

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

43 Years

Standard Ages

Adult

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Margaux Anav, Doctor	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uh Montpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility
D001724	Birth Weight

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D001835	Body Weight
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided