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

April 30, 2015 updated by: Bruce Shapiro M.D.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89117
        • Fertility Center of Las Vegas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: Blastocyst cryopreservation
Embryos cryopreserved at the blastocyst stage
Experimental: 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.
Procedure: Bipronuclear oocyte cryopreservation
Bipronuclear oocyte cryopreservation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing pregnancy rate
Time Frame: 10 weeks gestation
Ultrasonically confirmed fetal heart motion at 10 weeks gestation
10 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bruce Shapiro M.D.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

November 23, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (Estimate)

November 25, 2010

Study Record Updates

Last Update Posted (Estimate)

May 1, 2015

Last Update Submitted That Met QC Criteria

April 30, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAIRB 10-0018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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