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

Sophie Debrock

Status: Completed

Conditions: Subfertility

Treatments: Procedure: Day of vitrification

Study type: Interventional

Funder types: Other

Identifiers

NCT04196036

S60974

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: Female

Ages: 18 to 37 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Day 3 vitrification

Active Comparator group

Description:

Day of vitrification of supernumerary embryos is day 3

Treatment:

Procedure: Day of vitrification

Day 5 vitrification

Active Comparator group

Description:

Day of vitrification of supernumerary embryos is day5

Treatment:

Procedure: Day of vitrification