The Effect of Vitrification Versus Slow Freezing on Day 3: a Randomised Controlled Trial.

Sophie Debrock

Status: Completed

Conditions: Cryopreservation of Embryos

Treatments: Other: cryopreservation technique

Study type: Interventional

Funder types: Other

Identifiers

NCT02013024

S53410

Details and patient eligibility

About

Randomized controlled trial (RCT) testing the hypothesis that vitrification is superior to slow freezing.

Enrollment: 417 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients (with female age < 40 years)
• Patients undergoing a 1st oocyte retrieval for an IVF/Intracytoplasmatic Sperm Injection (ICSI) treatment
• Patients planned for an embryo transfer on day 3.
• Patients with supernumerary embryos of sufficient quality for freezing/vitrifying on day 3.
• Fresh personal (own oocytes)
• One inclusion in the study per patient.

Exclusion criteria

• Patients undergoing a 2nd or higher ranked oocyte retrieval after a fresh cycle with failed pregnancy.
• Female age ≥ 40 year
• Patients with Preimplantation Genetic Diagnosis (PGD)
• Patients with donor oocytes
• Patients with positive serology whose embryos may not be frozen.
• Patients planned for a transfer on day 2 or day 5.
• Patients receiving assisted hatching in the embryo transfer in the frozen cycles.
• Patients who have been included in the study before.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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417 participants in 2 patient groups

cryopreservation technique

Active Comparator group

Description:

slow freezing cryopreservation technique

Treatment:

Other: cryopreservation technique

vitrification cryopreservation technique

Active Comparator group

Description:

vitrification cryopreservation technique

Treatment:

Other: cryopreservation technique