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

NCT ID: NCT02013024

Last Updated: 2015-02-05

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

417 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-05-31

Brief Summary

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

Detailed Description

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Conditions

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Cryopreservation of Embryos

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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cryopreservation technique

slow freezing cryopreservation technique

Group Type ACTIVE_COMPARATOR

cryopreservation technique

Intervention Type OTHER

vitrification cryopreservation technique

vitrification cryopreservation technique

Group Type ACTIVE_COMPARATOR

cryopreservation technique

Intervention Type OTHER

Interventions

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cryopreservation technique

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 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

clinical embryologist PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Thomas M D'Hooghe, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

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Leuven University Fertility Center

Leuven, , Belgium

Site Status

Countries

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Belgium

References

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Debrock S, Peeraer K, Fernandez Gallardo E, De Neubourg D, Spiessens C, D'Hooghe TM. Vitrification of cleavage stage day 3 embryos results in higher live birth rates than conventional slow freezing: a RCT. Hum Reprod. 2015 Aug;30(8):1820-30. doi: 10.1093/humrep/dev134. Epub 2015 Jun 18.

Reference Type DERIVED
PMID: 26089301 (View on PubMed)

Other Identifiers

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S53410

Identifier Type: -

Identifier Source: org_study_id

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