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OpenTrials
Completed

NCT Number: NCT01247987

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fertility Center of Las Vegas

Las Vegas, Nevada, 89117, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Embryo biopsy (a.k.a. pre-implantation genetic diagnosis (PGD)).
  • 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.
  • No minors will be enrolled in this study.

Treatment and study plan

Blastocyst cryopreservation

Procedure

Embryos cryopreserved at the blastocyst stage

Bipronuclear oocyte cryopreservation

Procedure

Bipronuclear oocyte cryopreservation.

Primary outcomes

  1. Ongoing pregnancy rate

    Time frame: 10 weeks gestation

    Ultrasonically confirmed fetal heart motion at 10 weeks gestation

Sponsors and collaborators

Lead sponsor

Bruce Shapiro M.D.

Industry

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Nov 25, 2010
Registry last updated
May 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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