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

Bruce Shapiro M.D.

Status: Completed

Conditions: Infertility

Treatments: Procedure: Bipronuclear oocyte cryopreservation; Procedure: Blastocyst cryopreservation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01247987

SAIRB 10-0018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Blastocyst cryopreservation

Active Comparator group

Description:

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.

Treatment:

Procedure: Blastocyst cryopreservation

Bipronuclear oocyte cryopreservation

Experimental group

Description:

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.

Treatment:

Procedure: Bipronuclear oocyte cryopreservation