Comparison of Transfers of Thawed Blastocysts Versus Blastocysts Derived From Thawed Bipronuclear Oocytes
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2010
CompletedFirst Posted
Study publicly available on registry
November 25, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedMay 1, 2015
April 1, 2015
4 years
November 23, 2010
April 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ongoing pregnancy rate
Ultrasonically confirmed fetal heart motion at 10 weeks gestation
10 weeks gestation
Study Arms (2)
Blastocyst cryopreservation
ACTIVE COMPARATORSubjects 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
EXPERIMENTALSubjects 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.
Interventions
Embryos cryopreserved at the blastocyst stage
Bipronuclear oocyte cryopreservation.
Eligibility Criteria
You may qualify if:
- 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.
- to 40 years of age.
- Ability to read and understand English.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fertility Center of Las Vegas
Las Vegas, Nevada, 89117, United States
Related Publications (1)
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.
PMID: 26255088DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Medica Director
Study Record Dates
First Submitted
November 23, 2010
First Posted
November 25, 2010
Study Start
December 1, 2010
Primary Completion
December 1, 2014
Study Completion
April 1, 2015
Last Updated
May 1, 2015
Record last verified: 2015-04