IVF Hyper-responders: Oocyte Vitrification Compared With Embryo Freezing
1 other identifier
interventional
11
1 country
1
Brief Summary
The chances to achieve pregnancy after retrieving \>15 oocytes are not good, probably because of bad effect on the endometrium (uterine inner lining). Therefore, in most such cases the investigators prefer to freeze all embryos, and transfer in a thaw cycle. With the introduction of oocyte vitrification (very fast cooling) technology, a new option emerged: to freeze un-fertilized eggs, to be fertilized and used later in a thaw cycle. The purpose of this study is to compare the outcome of these two approaches.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2014
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
December 30, 2013
CompletedFirst Posted
Study publicly available on registry
January 1, 2014
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedResults Posted
Study results publicly available
June 8, 2015
CompletedJune 8, 2015
May 1, 2015
10 months
December 30, 2013
April 29, 2015
May 20, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Fetal Heart Activity 1 Month Post Embryo Transfer
Fetal heart activity as demonsrated by vaginal ultrasound 1 month post embryo transfer
1 month after embryo transfer
Study Arms (2)
oocyte vitrification
EXPERIMENTALAll retrieved mature oocytes will be vitrified.
embryo freezing
ACTIVE COMPARATORAll retrieved oocytes will be fertilized, and resulting embryos will be frozen.
Interventions
Eligibility Criteria
You may qualify if:
- IVF patients
- ovulation trigger with Decapeptyl 0.2 mg because of ovarian hyper-response: E2 on trigger day .12,000 pmol/l and/or \>15 oocytes.
- Normal uterus
You may not qualify if:
- \<20% fertilization rate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IVF Unit, Rambam medical Center
Haifa, Israel, 31096, Israel
Related Publications (1)
Devroey P, Polyzos NP, Blockeel C. An OHSS-Free Clinic by segmentation of IVF treatment. Hum Reprod. 2011 Oct;26(10):2593-7. doi: 10.1093/humrep/der251. Epub 2011 Aug 9.
PMID: 21828116BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Shahar Kol , Director IVF Unit
- Organization
- Rambam health Care campus
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, IVF Unit
Study Record Dates
First Submitted
December 30, 2013
First Posted
January 1, 2014
Study Start
January 1, 2014
Primary Completion
November 1, 2014
Study Completion
April 1, 2015
Last Updated
June 8, 2015
Results First Posted
June 8, 2015
Record last verified: 2015-05