New Device to Maintain the Embryo Temperature During Transfer
EmbryoTemp
A New System for Preventing Thermal Stress During Embryo Transfer
1 other identifier
interventional
352
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 28, 2015
CompletedFirst Posted
Study publicly available on registry
January 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedAugust 9, 2019
August 1, 2019
3.9 years
September 28, 2015
August 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Ongoing Pregnancy rate
Achieving an ongoing pregnancy after embryo transfer
Ongoing pregnancy until 28th week of gestation
Secondary Outcomes (2)
Miscarriage rate
Loss of pregnancy up to 12 weeks of gestation
Implantation rate
Embryo implantation after 6-7 weeks of gestation
Study Arms (2)
Conventional transfer
NO INTERVENTIONThis arm is the control group (conventional embryo transfer protocol) where there is no intervention.
Thermostable device transfer
EXPERIMENTALThis arm is the study group: embryo transfer protocol using a new thermostable device.
Interventions
Investigators place the catheter with the loaded embryos into a plastic device at 37ºC in order to maintain the temperature
Eligibility Criteria
You may qualify if:
- Cryo-transfer cycles: transfer of embryos vitrified in previous cycles receiving donated eggs inseminated with either conjugal or donated sperm from Instituto Bernabeu bank.
You may not qualify if:
- Fresh cycles: transfer of fresh embryos (coming from donated or own eggs), and cryo-transfer cycles from vitrified embryos coming from own oocytes.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto Bernabeu
Alicante, 03016, Spain
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Gynecologist; M D; Ph D
Study Record Dates
First Submitted
September 28, 2015
First Posted
January 8, 2016
Study Start
April 1, 2015
Primary Completion
March 1, 2019
Study Completion
December 1, 2019
Last Updated
August 9, 2019
Record last verified: 2019-08