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NCT04196036 Clinical Trial

Day 3 Fresh Transfer Followed by Day 3 or Day 5 Vitrification of Supernumerary Embryos

Subfertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04196036
Other study ID # S60974
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 15, 2018
Est. completion date December 30, 2021

Study information
Verified date March 2022
Source KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date December 30, 2021
Est. primary completion date July 31, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 37 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Day of vitrification
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

Locations
Country Name City State
Belgium Leuven University Fertility Center Leuven

Sponsors (1)
Lead Sponsor Collaborator
Sophie Debrock

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary cumulative pregnancy rate The cumulative pregnancy rate after all transfers (fresh and/or frozen embryo transfer cycles) Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year
Secondary cost analysis cost analysis of day 3 and day 5 vitrification strategy Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year
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