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New Device to Maintain the Embryo Temperature During Transfer

A New System for Preventing Thermal Stress During Embryo Transfer

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02650310
Acronym
EmbryoTemp
Enrollment
352
Registered
2016-01-08
Start date
2015-04-30
Completion date
2019-12-31
Last updated
2019-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Embryo Transfer

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.

Interventions

DEVICEThermostable device

Investigators place the catheter with the loaded embryos into a plastic device at 37ºC in order to maintain the temperature

Sponsors

Rafael Bernabeu Pérez
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Ongoing Pregnancy rateOngoing pregnancy until 28th week of gestationAchieving an ongoing pregnancy after embryo transfer

Secondary

MeasureTime frameDescription
Miscarriage rateLoss of pregnancy up to 12 weeks of gestationTo know the embryonic loss rate after implantation
Implantation rateEmbryo implantation after 6-7 weeks of gestationTo know the embryo implantation rate after the embryo transfer

Countries

Spain

Contacts

Primary ContactJorge Ten Morro, Ph.D.
jten@institutobernabeu.com696914882
Backup ContactJorge Ten Morro, Ph.D
jten@institutobernabeu.com696914882

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026