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Completed

NCT Number: NCT04196036

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

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.

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Key information

Conditions

Subfertility Genital Diseases Infertility Urogenital Diseases

Age range

18 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Leuven University Fertility Center

Leuven, 3000, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Day of vitrification

Procedure

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 outcomes

  1. cumulative pregnancy rate

    Time frame: 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 outcomes

  1. cost analysis

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Sophie Debrock

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Dec 12, 2019
Registry last updated
Mar 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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