New Device to Maintain the Embryo Temperature During Transfer

Not Applicable

• Conditions: Embryo Transfer
• Interventions: Device: Thermostable device

• Registration Number: NCT02650310
• Lead Sponsor: Rafael Bernabeu Pérez

Brief Summary

The embryo transfer implies transportation from the incubator where they have been at 37 ° C, to the transfer catheter inside a laminar flow hood whose working surface is also maintained at 37 ° C. . From the laboratory to the operating room the embryo is exposed to a temperature drop, and consequently thermal stress occurs, which may compromise its future viability.

The aim of this study is to assess the possible improvement in the clinical results when the embryos are transported in a stable device to avoid the drop in temperature throughout the transfer process.

With the use of this thermosetting device heated to 37 ° C, researchers expect a 15% increase in pregnancy rates.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2016-01-07
• Study First Posted: 2016-01-08
• Primary Completion: 2019-03
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-08
• Last Update Posted: 2019-08-09
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 352

Inclusion Criteria

• Cryo-transfer cycles: transfer of embryos vitrified in previous cycles receiving donated eggs inseminated with either conjugal or donated sperm from Instituto Bernabeu bank.

Exclusion Criteria

• Fresh cycles: transfer of fresh embryos (coming from donated or own eggs), and cryo-transfer cycles from vitrified embryos coming from own oocytes.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thermostable device transfer	Thermostable device	This arm is the study group: embryo transfer protocol using a new thermostable device.

Primary Outcome Measures

Name	Time	Method
Ongoing Pregnancy rate	Ongoing pregnancy until 28th week of gestation	Achieving an ongoing pregnancy after embryo transfer

Secondary Outcome Measures

Name	Time	Method
Miscarriage rate	Loss of pregnancy up to 12 weeks of gestation	To know the embryonic loss rate after implantation
Implantation rate	Embryo implantation after 6-7 weeks of gestation	To know the embryo implantation rate after the embryo transfer

Trial Locations

Locations (1)

Instituto Bernabeu; 🇪🇸 Alicante, Spain