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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04196036
Enrollment
150
Registered
2019-12-12
Start date
2018-01-15
Completion date
2021-12-30
Last updated
2022-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subfertility

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.

Interventions

PROCEDUREDay 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

Sponsors

Sophie Debrock
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
cumulative pregnancy rateCumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 yearThe cumulative pregnancy rate after all transfers (fresh and/or frozen embryo transfer cycles)

Secondary

MeasureTime frameDescription
cost analysisCumulative pregnancy is measured after two consecutive IVF cycles including fresh and frozen transfers which might take about 1 yearcost analysis of day 3 and day 5 vitrification strategy

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026