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OpenTrials
Completed

NCT Number: NCT03548532

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

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.

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Key information

Conditions

Temperature; Extreme, Exposure

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Brussel

Brussels, Brussels Capital, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

G210 incubator

Device

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

Other names: Ksystems

Primary outcomes

  1. Clinical pregnancy

    Time frame: 7 weeks

    ultrasound: sac and fetal heartbeat positive

Secondary outcomes

  1. Fertilization rate

    Time frame: 1 day

    number of fertilized oocytes, per number of injected oocytes

  2. embryo development/utilization rate

    Time frame: 6 days

    number of embryos transferred or cryopreserved per fertilized oocytes

  3. live birth rate of the fresh cycle

    Time frame: 43 weeks

    number of live births per started cycle

  4. cumulative live birth rate per cycle

    Time frame: 104 weeks

    fresh and frozen embryo transfer: outcome of the deliveries

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

Embryo Culture At a Constant Temperature of 36.6°C or 37.1°C: a Randomized Controlled Trial

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Jun 7, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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