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

Bruce Shapiro M.D.140 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

140

Conditions

Infertility

Interventions

Blastocyst cryopreservationPROCEDURE

Embryos cryopreserved at the blastocyst stage

Bipronuclear oocyte cryopreservationPROCEDURE

Bipronuclear oocyte cryopreservation.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Fertility Center of Las Vegas

Las Vegas, Nevada, United States

Outcomes

Primary Outcomes

Ongoing pregnancy rate

Ultrasonically confirmed fetal heart motion at 10 weeks gestation

Time frame: 10 weeks gestation

Data from ClinicalTrials.gov

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