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Clinical Trials/NCT04196036
NCT04196036
Completed
Not Applicable

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

Sophie Debrock1 site in 1 country150 target enrollmentJanuary 15, 2018
ConditionsSubfertility

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Subfertility
Sponsor
Sophie Debrock
Enrollment
150
Locations
1
Primary Endpoint
cumulative pregnancy rate
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 15, 2018
End Date
December 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Sophie Debrock
Responsible Party
Sponsor Investigator
Principal Investigator

Sophie Debrock

Professor, PhD

KU Leuven

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

Study Sites (1)

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