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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Blastocyst cryopreservation
* Procedure: Bipronuclear oocyte cryopreservation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blastocyst cryopreservation<br>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<br>* Embryos cryopreserved at the blastocyst stage<br>|
| Experimental: Bipronuclear oocyte cryopreservation<br>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<br>* Bipronuclear oocyte cryopreservation.<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IVF, assisted reproduction, embryo transfer