New Device to Maintain the Embryo Temperature During Transfer (EmbryoTemp)

Rafael Bernabeu Pérez

Status: Unknown

Conditions: Embryo Transfer

Treatments: Device: Thermostable device

Study type: Interventional

Funder types: Other

Identifiers

NCT02650310

Instituto Bernabeu Group

Details and patient eligibility

About

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.

Enrollment: 352 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

352 participants in 2 patient groups

Conventional transfer

No Intervention group

Description:

This arm is the control group (conventional embryo transfer protocol) where there is no intervention.

Thermostable device transfer

Experimental group

Description:

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

Treatment:

Device: Thermostable device