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

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ClinicalTrials.gov Identifier: NCT03548532
Recruitment Status : Recruiting
First Posted : June 7, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
Neelke De Munck, Universitair Ziekenhuis Brussel

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Temperature; Extreme, Exposure Device: G210 incubator Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Embryo Culture at a Constant Temperature of 36.6°C or 37.1°C: A Randomized Controlled Trial
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : September 1, 2019

Arm Intervention/treatment
Active Comparator: 36.6°C
Embryos of these patients will be cultured at 36.6°C from day 0 after ICSI, untill day 6.
Device: G210 incubator
very stable culture temperature, up to 0.1°C, in both arms
Other Name: Ksystems

Experimental: 37.1°C
Embryos of these patients will be cultured at 37.1°C from day 0 after ICSI, untill day 6.
Device: G210 incubator
very stable culture temperature, up to 0.1°C, in both arms
Other Name: Ksystems




Primary Outcome Measures :
  1. Clinical pregnancy [ Time Frame: 7 weeks ]
    ultrasound: sac and fetal heartbeat positive


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03548532


Contacts
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Contact: Neelke De Munck, PhD 024776694 ext 0032 neelke.demunck@uzbrussel.be
Contact: Greta Verheyen, PhD 024774042 ext 0032 greta.verheyen@uzbrussel.be

Locations
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Belgium
Universitair Ziekenhuis Brussel Recruiting
Brussels, Belgium, 1090
Contact: Neelke De Munck, MSc.    024776694 ext 0032    neelkedemunck@gmail.com   
Principal Investigator: Neelke De Munck, MSc.         
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Study Director: Greta Verheyen, PhD UZBrussel

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Responsible Party: Neelke De Munck, PhD, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT03548532     History of Changes
Other Study ID Numbers: 2017/060
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: For statistical Analysis
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: within 6 months after study completion
Access Criteria: Only relevant information will be given to the statistician (who is also a clinical doctor in our centre)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Neelke De Munck, Universitair Ziekenhuis Brussel:
temperature