Back to resultsDay 3 Fresh Transfer Followed by Day 3 or Day 5 Vitrification of Supernumerary Embryos
Primary Purpose
Subfertility
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Day of vitrification
Sponsored by
About this trial
This is an interventional treatment trial for Subfertility
Eligibility Criteria
Inclusion Criteria:
- subfertile women planned for the first or second oocyte retrieval for in vitro fertilisation (IVF)/Intracytoplasmic sperm injection (ICSI) treatment
- who are older than 18 and less than 38 years old
- who have normal Follicle Stimulating Hormone (FSH) and normal Anti-Mullerian Hormone (AMH) levels
Exclusion Criteria:
- treatment with donor oocytes or donor embryos
- patients planned for Pre-implantation Genetic Diagnosis (PGD)
- Patients with BMI>30
- patients with endometriosis grade III-IV
Sites / Locations
- Leuven University Fertility Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Day 3 vitrification
Day 5 vitrification
Arm Description
Day of vitrification of supernumerary embryos is day 3
Day of vitrification of supernumerary embryos is day5
Outcomes
Primary Outcome Measures
cumulative pregnancy rate
The cumulative pregnancy rate after all transfers (fresh and/or frozen embryo transfer cycles)
Secondary Outcome Measures
cost analysis
cost analysis of day 3 and day 5 vitrification strategy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04196036
Brief Title
Day 3 Fresh Transfer Followed by Day 3 or Day 5 Vitrification of Supernumerary Embryos
Official Title
Cumulative Pregnancy Rates and Direct Healthcare Cost Analysis of Two Different Strategies: Fresh Cleavage-stage Embryo Transfer (ET) on Day 3 With Vitrification of Supernumerary Embryos on Day 3 Versus Day 5
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sophie Debrock
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This monocenter academic study aims to evaluate the effectiveness and cost effectiveness of two different strategies: fresh Embryo Transfer (ET) on day 3 followed by cryopreservation of cleavage-stage (Day 3) embryos versus blastocyst-stage (Day 5) embryos.
The primary outcome is the cumulative pregnancy rate after all transfers (fresh and/or frozen embryo transfer cycles which might take about 1 year), up to two sequential cycles. The secondary outcome concerns a cost analysis of both strategies from the healthcare payer's perspective.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subfertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Day 3 vitrification
Arm Type
Active Comparator
Arm Description
Day of vitrification of supernumerary embryos is day 3
Arm Title
Day 5 vitrification
Arm Type
Active Comparator
Arm Description
Day of vitrification of supernumerary embryos is day5
Intervention Type
Procedure
Intervention Name(s)
Day of vitrification
Intervention Description
Supernumerary embryos after fresh transfer on Day 3 after oocyte aspiration are either vitrified on Day 3 or are kept in culture until Day 5 and vitrified on Day 5
Primary Outcome Measure Information:
Title
cumulative pregnancy rate
Description
The cumulative pregnancy rate after all transfers (fresh and/or frozen embryo transfer cycles)
Time Frame
Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year
Secondary Outcome Measure Information:
Title
cost analysis
Description
cost analysis of day 3 and day 5 vitrification strategy
Time Frame
Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
subfertile women planned for the first or second oocyte retrieval for in vitro fertilisation (IVF)/Intracytoplasmic sperm injection (ICSI) treatment
who are older than 18 and less than 38 years old
who have normal Follicle Stimulating Hormone (FSH) and normal Anti-Mullerian Hormone (AMH) levels
Exclusion Criteria:
treatment with donor oocytes or donor embryos
patients planned for Pre-implantation Genetic Diagnosis (PGD)
Patients with BMI>30
patients with endometriosis grade III-IV
Facility Information:
Facility Name
Leuven University Fertility Center
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Day 3 Fresh Transfer Followed by Day 3 or Day 5 Vitrification of Supernumerary Embryos
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