---
title: New Device to Maintain the Embryo Temperature During Transfer
nct_id: NCT02650310
overall_status: UNKNOWN
phase: NA
sponsor: Rafael Bernabeu Pérez
study_type: INTERVENTIONAL
primary_condition: Embryo Transfer
countries: Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02650310.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02650310"
ct_last_update_post_date: 2019-08-09
last_seen_at: "2026-05-12T06:07:21.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# New Device to Maintain the Embryo Temperature During Transfer

**Official Title:** A New System for Preventing Thermal Stress During Embryo Transfer

**NCT ID:** [NCT02650310](https://clinicaltrials.gov/study/NCT02650310)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 352
- **Lead Sponsor:** Rafael Bernabeu Pérez
- **Conditions:** Embryo Transfer
- **Start Date:** 2015-04
- **Completion Date:** 2019-12
- **CT.gov Last Update:** 2019-08-09

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 50 Years
- **Sex:** FEMALE
- **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.
```

## Arms

- **Conventional transfer** (NO_INTERVENTION) — This arm is the control group (conventional embryo transfer protocol) where there is no intervention.
- **Thermostable device transfer** (EXPERIMENTAL) — This arm is the study group: embryo transfer protocol using a new thermostable device.

## Interventions

- **Thermostable device** (DEVICE) — Investigators place the catheter with the loaded embryos into a plastic device at 37ºC in order to maintain the temperature

## Primary Outcomes

- **Ongoing Pregnancy rate** _(time frame: Ongoing pregnancy until 28th week of gestation)_ — Achieving an ongoing pregnancy after embryo transfer

## Secondary Outcomes

- **Miscarriage rate** _(time frame: Loss of pregnancy up to 12 weeks of gestation)_
- **Implantation rate** _(time frame: Embryo implantation after 6-7 weeks of gestation)_

## Locations (1)

- Instituto Bernabeu, Alicante, Spain — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.instituto bernabeu|alicante||spain` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02650310.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02650310*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*