NCT04196036

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 15, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

January 15, 2018

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

March 11, 2022

Status Verified

March 1, 2022

Enrollment Period

2.5 years

First QC Date

January 15, 2018

Last Update Submit

March 10, 2022

Conditions

Subfertility

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • cost analysis

    Cumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 year

Study Arms (2)

Day 3 vitrification

ACTIVE COMPARATOR

Day of vitrification of supernumerary embryos is day 3

Procedure: Day of vitrification

Day 5 vitrification

ACTIVE COMPARATOR

Day of vitrification of supernumerary embryos is day5

Procedure: Day of vitrification

Interventions

Day of vitrificationPROCEDURE

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

Day 3 vitrificationDay 5 vitrification

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Leuven University Fertility Center

Leuven, 3000, Belgium

Location

Related Publications (1)

  • Mengels A, Van Muylder A, Peeraer K, Luyten J, Laenen A, Spiessens C, Debrock S. Cumulative pregnancy rates of two strategies: Day 3 fresh embryo transfer followed by Day 3 or Day 5/6 vitrification and embryo transfer: a randomized controlled trial. Hum Reprod. 2024 Jan 5;39(1):62-73. doi: 10.1093/humrep/dead222.

    PMID: 37886820DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, PhD

Study Record Dates

First Submitted

January 15, 2018

First Posted

December 12, 2019

Study Start

January 15, 2018

Primary Completion

July 31, 2020

Study Completion

December 30, 2021

Last Updated

March 11, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)