Back to resultsComparison of Transfers of Thawed Blastocysts Versus Blastocysts Derived From Thawed Bipronuclear Oocytes
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blastocyst cryopreservation
Bipronuclear oocyte cryopreservation
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring IVF, assisted reproduction, embryo transfer
Eligibility Criteria
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.
Sites / Locations
- Fertility Center of Las Vegas
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Blastocyst cryopreservation
Bipronuclear oocyte cryopreservation
Arm 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.
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.
Outcomes
Primary Outcome Measures
Ongoing pregnancy rate
Ultrasonically confirmed fetal heart motion at 10 weeks gestation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01247987
Brief Title
Comparison of Transfers of Thawed Blastocysts Versus Blastocysts Derived From Thawed Bipronuclear Oocytes
Official Title
Comparison of Transfers of Thawed Blastocysts Versus Blastocysts Derived From Thawed Bipronuclear Oocytes
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Bruce Shapiro M.D.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF, assisted reproduction, embryo transfer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blastocyst cryopreservation
Arm Type
Active Comparator
Arm 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.
Arm Title
Bipronuclear oocyte cryopreservation
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Blastocyst cryopreservation
Intervention Description
Embryos cryopreserved at the blastocyst stage
Intervention Type
Procedure
Intervention Name(s)
Bipronuclear oocyte cryopreservation
Intervention Description
Bipronuclear oocyte cryopreservation.
Primary Outcome Measure Information:
Title
Ongoing pregnancy rate
Description
Ultrasonically confirmed fetal heart motion at 10 weeks gestation
Time Frame
10 weeks gestation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Fertility Center of Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89117
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26255088
Citation
Shapiro BS, Daneshmand ST, Garner FC, Aguirre M, Hudson C. Freeze-all at the blastocyst or bipronuclear stage: a randomized clinical trial. Fertil Steril. 2015 Nov;104(5):1138-44. doi: 10.1016/j.fertnstert.2015.07.1141. Epub 2015 Aug 5.
Results Reference
derived
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Comparison of Transfers of Thawed Blastocysts Versus Blastocysts Derived From Thawed Bipronuclear Oocytes
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