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

Not Applicable

Completed

• Conditions: Subfertility
• Interventions: Procedure: Day of vitrification

• Registration Number: NCT04196036
• Lead Sponsor: Sophie Debrock

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-15
• Study First Submitted: 2018-01-15
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Primary Completion: 2020-07-31
• Study Completion: 2021-12-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-10
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Day 5 vitrification	Day of vitrification	Day of vitrification of supernumerary embryos is day5
Day 3 vitrification	Day of vitrification	Day of vitrification of supernumerary embryos is day 3

Primary Outcome Measures

Name	Time	Method
cumulative pregnancy rate	Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year	The cumulative pregnancy rate after all transfers (fresh and/or frozen embryo transfer cycles)

Secondary Outcome Measures

Name	Time	Method
cost analysis	Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year	cost analysis of day 3 and day 5 vitrification strategy

Trial Locations

Locations (1)

Leuven University Fertility Center; 🇧🇪 Leuven, Belgium