Embryo Culture At a Constant Temperature of 36.6°C or 37.1°C

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2023-01-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

On the day of oocyte retrieval, participants will be randomized to stable culture at 37.1°C or 36.6°C with the ultimate aim of finding a difference in clincial pregnancies.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Optimizing the Temperature for Embryo Culture in In Vitro Fertilization

NCT01506089

Infertility

COMPLETED NA

Clinical Validation of Embryo Cinematography

NCT01549262

Embryo Diagnosis and Selection

COMPLETED NA

Embryo Development in Microfluidics System of Culture

NCT01003548

Infertility

UNKNOWN PHASE2

Incubator Temperature for Culturing Human Embryos

NCT01706900

Embryo Culture

COMPLETED NA

Investigating the Cryopreserved Blastocyst's ImplantatiOn Potential After Genetic Screening

NCT03173885

Infertility Preimplantation Genetic Screening

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A previous study in our centre analysed stable embryo culture at 36.6°C and 37.1°C, on sibling oocytes. The primary aim was to analyse possible differneces in embryo development (utilization rate) up to day 5/6. In this study, the investigators found a high difference in clinical pregnancy rate between both groups (46.4% versus 77.4%). Since this study was not powered to find differences in clincial pregnancy rates between both groups, this RCT was especially powered as a superiority trial to find differences in clincial pregnancy rates between both groups. On the day of oocyte retrieval, patients will be allocated to culture at one of both temperatures.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Temperature; Extreme, Exposure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Based on the randomisation list, patients fulfilling the inclusion criteria will be assigned to one of each arm. A total of 119 patients are needed in every arm in this superiority trial.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

36.6°C

Embryos of these patients will be cultured at 36.6°C from day 0 after ICSI, untill day 6.

Group Type ACTIVE_COMPARATOR

G210 incubator

Intervention Type DEVICE

very stable culture temperature, up to 0.1°C, in both arms

37.1°C

Embryos of these patients will be cultured at 37.1°C from day 0 after ICSI, untill day 6.

Group Type EXPERIMENTAL

G210 incubator

Intervention Type DEVICE

very stable culture temperature, up to 0.1°C, in both arms

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

G210 incubator

very stable culture temperature, up to 0.1°C, in both arms

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ksystems

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Day 5 transfer
* Single embryo transfer
* Only ejaculated sperm (fresh or frozen, autologous or heterologous)
* BMI \<35
* Age \<40 years
* Cycle rank \<3 for the current child
* Last ultrasound: 8 follicles of at least 12 mm
* At least 6 mature oocytes

Exclusion Criteria

* IVF
* IVF versus ICSI
* Failed fertilization in previous cycle
* no previous cycle without embryo transfer
* No use of Ca ionophores for embryo quality or fertilization problems

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes