Day 3 Embryo Cryopreservation: Metabolic and Viability Analysis

NCT ID: NCT00608010

Last Updated: 2008-02-06

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

186 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Brief Summary

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Embryo preservation through freezing plays a significant role in human assisted reproduction. It provides an opportunity for patients to have more than one attempt following an ovarian stimulation cycle, thereby decreasing the exposure of patients to exogenous gonadotrophins and improving cumulative pregnancy rates. The purpose of this study is to compare effectiveness of two different freezing methods.

Detailed Description

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Conditions

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Fertilization in Vitro Preservation of Supernumerary Embryos

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Vitrification

Group Type EXPERIMENTAL

Vitrification

Intervention Type PROCEDURE

Embryos were vitrified according to a previously described technique

2

Slow freezing

Group Type ACTIVE_COMPARATOR

Slow freezing

Intervention Type PROCEDURE

Embryos were frozen with slow freezing technique

Interventions

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Vitrification

Embryos were vitrified according to a previously described technique

Intervention Type PROCEDURE

Slow freezing

Embryos were frozen with slow freezing technique

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* ICSI with own gametes
* Couples who did not wish to cryopreserve their excess embryos for possible transfer in a future cyle
* Donating excess embryos for research purposes

Exclusion Criteria

* Embryos derived from surgically retrieved spermatozoa
* Blastocysts
* Embryos of low quality (Grade 3 or 4 according to Hardarson)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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V.K.V. American Hospital, Istanbul

OTHER

Sponsor Role lead

Responsible Party

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American Hospital of Istanbul

Principal Investigators

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Basak Balaban, BSc

Role: PRINCIPAL_INVESTIGATOR

American Hospital of Istanbul

Locations

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American Hospital of Istanbul

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Balaban B, Urman B, Ata B, Isiklar A, Larman MG, Hamilton R, Gardner DK. A randomized controlled study of human Day 3 embryo cryopreservation by slow freezing or vitrification: vitrification is associated with higher survival, metabolism and blastocyst formation. Hum Reprod. 2008 Sep;23(9):1976-82. doi: 10.1093/humrep/den222. Epub 2008 Jun 10.

Reference Type DERIVED
PMID: 18544577 (View on PubMed)

Other Identifiers

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AH-ART-06/13

Identifier Type: -

Identifier Source: org_study_id

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