Comparison of Transfers of Thawed Blastocysts Versus Blastocysts Derived From Thawed Bipronuclear Oocytes

NCT ID: NCT01247987

Last Updated: 2015-05-01

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

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2015-04-30

Brief Summary

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The purpose of this study is to determine if cryopreservation at the blastocyst stage followed by embryo thaw and transfer is as effective as cryopreservation of bipronuclear oocytes followed by post-thaw extended culture (PTEC), and blastocyst transfer. Effectiveness will be measured by the rate of ongoing pregnancy at 10 weeks gestation.

Detailed Description

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Subjects will be randomized to one of two study groups during their cycles of in vitro fertilization (IVF). In one group, the subjects will have all of their embryos cryopreserved at the blastocyst stage, followed by thaw and transfer in a subsequent cycle. In the other group, subjects will have all of their embryos cryopreserved at the bipronuclear oocyte stage, followed by thaw, extended culture, and transfer in a subsequent cycle.

Conditions

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Infertility

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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Blastocyst cryopreservation

Subjects randomly assigned to this arm of the study will have all of their embryos cryopreserved at the blastocyst stage, followed by thaw and transfer in a subsequent menstrual cycle.

Group Type ACTIVE_COMPARATOR

Blastocyst cryopreservation

Intervention Type PROCEDURE

Embryos cryopreserved at the blastocyst stage

Bipronuclear oocyte cryopreservation

Subjects randomly assigned to this arm of the study will have all of their bipronuclear oocytes cryopreserved, followed by thaw, extended culture, and transfer in a subsequent menstrual cycle.

Group Type EXPERIMENTAL

Bipronuclear oocyte cryopreservation

Intervention Type PROCEDURE

Bipronuclear oocyte cryopreservation.

Interventions

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Blastocyst cryopreservation

Embryos cryopreserved at the blastocyst stage

Intervention Type PROCEDURE

Bipronuclear oocyte cryopreservation

Bipronuclear oocyte cryopreservation.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Female patient seeking autologous in vitro fertilization (IVF) treatment.
2. Cycle day 3 serum concentration of follicle stimulating hormone (FSH) less than 10.0 IU/l.
3. Baseline total antral follicle count observed on ultrasound with at least eight antral follicles.
4. 18 to 40 years of age.
5. Ability to read and understand English.

Exclusion Criteria

1. Embryo biopsy (a.k.a. pre-implantation genetic diagnosis (PGD)).
2. Any condition that, in the opinion of the physician or principal investigator, would place the patient at undue risk under this protocol or would otherwise make the protocol inappropriate for that subject.
3. No minors will be enrolled in this study.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Bruce Shapiro M.D.

INDUSTRY

Sponsor Role lead

Responsible Party

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Bruce Shapiro M.D.

Medica Director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Fertility Center of Las Vegas

Las Vegas, Nevada, United States

Site Status

Countries

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United States

References

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Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Hudson C. Freeze-all at the blastocyst or bipronuclear stage: a randomized clinical trial. Fertil Steril. 2015 Nov;104(5):1138-44. doi: 10.1016/j.fertnstert.2015.07.1141. Epub 2015 Aug 5.

Reference Type DERIVED
PMID: 26255088 (View on PubMed)

Other Identifiers

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SAIRB 10-0018

Identifier Type: -

Identifier Source: org_study_id

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