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

NCT ID: NCT04196036

Last Updated: 2022-03-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-15

Study Completion Date

2021-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Subfertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Day 3 vitrification

Day of vitrification of supernumerary embryos is day 3

Group Type ACTIVE_COMPARATOR

Day of vitrification

Intervention Type 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

Day 5 vitrification

Day of vitrification of supernumerary embryos is day5

Group Type ACTIVE_COMPARATOR

Day of vitrification

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

37 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sophie Debrock

OTHER

Sponsor Role lead

Responsible Party

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Sophie Debrock

Professor, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Leuven University Fertility Center

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 37886820 (View on PubMed)

Other Identifiers

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S60974

Identifier Type: -

Identifier Source: org_study_id

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