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

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Procedure: Blastocyst cryopreservation; Procedure: Bipronuclear oocyte cryopreservation

• Registration Number: NCT01247987
• Lead Sponsor: Bruce Shapiro M.D.

Brief Summary

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

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 Timeline

• Study First Submitted: 2010-11-23
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-25
• Study Start: 2010-12
• Primary Completion: 2014-12
• Status Verified: 2015-04
• Study Completion: 2015-04
• Last Update Submitted: 2015-04-30
• Last Update Posted: 2015-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blastocyst cryopreservation	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.
Bipronuclear oocyte cryopreservation	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.

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	10 weeks gestation	Ultrasonically confirmed fetal heart motion at 10 weeks gestation

Trial Locations

Locations (1)

Fertility Center of Las Vegas; 🇺🇸 Las Vegas, Nevada, United States