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

Sponsor

Sophie Debrock (Other)

Overall Status

Completed

CT.gov ID

NCT04196036

Collaborator

(none)

150

Enrollment

Location

Arms

47.5

Actual Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Subfertility	Procedure: Day of vitrification	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Jan 15, 2018

Actual Primary Completion Date :

Jul 31, 2020

Actual Study Completion Date :

Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Day 3 vitrification Day of vitrification of supernumerary embryos is day 3	Procedure: Day 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
Active Comparator: Day 5 vitrification Day of vitrification of supernumerary embryos is day5	Procedure: Day 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

Arm

Intervention/Treatment

Active Comparator: Day 3 vitrification

Day of vitrification of supernumerary embryos is day 3

Procedure: Day 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

Active Comparator: Day 5 vitrification

Day of vitrification of supernumerary embryos is day5

Procedure: Day 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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 37 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leuven University Fertility Center	Leuven		Belgium	3000

Sponsors and Collaborators

Sophie Debrock

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sophie Debrock, Professor, PhD, KU Leuven

ClinicalTrials.gov Identifier:

NCT04196036

Other Study ID Numbers:

S60974

First Posted:

Dec 12, 2019

Last Update Posted:

Mar 11, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Mar 11, 2022