A Comparison of Ongoing Pregnancy Rate Between Cleavage Stage and Early Compacting Embryo Transfer at 66±2 Hours After ICSI Using Single Step Culture Medium
1 other identifier
interventional
430
1 country
1
Brief Summary
A comparison of ongoing pregnancy rate between cleavage stage and early compacting embryo transfer at 66±2 hours after ICSI using single step culture medium
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2016
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 25, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedFirst Posted
Study publicly available on registry
December 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJuly 17, 2017
July 1, 2017
11 months
November 25, 2016
July 12, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The primary outcome measure was ongoing pregnancy rate, defined as a pregnancy with a detectable heart rate at 12 weeks of gestation or beyond.
12 weeks
Secondary Outcomes (4)
Clinical pregnancy rate, defined as the presence of a gestational sac under ultrasonography
7 weeks
Implantation rate (number of gestational sacs on ultrasound at 7 weeks / total number of embryos transferred x 100).
7 weeks
Ectopic pregnancy rate, defined as the ectopic nidation of a pregnancy, confirmed with sonography or laparoscopy
7 weeks
Miscarriage rate, defined as the loss of a pregnancy prior to 12 weeks gestation
12 weeks
Study Arms (2)
Early compaction embryo group
OTHERpatients have compacting embryos at 66±2 hours after ICSI
Cleavage stage embryo group
OTHERpatients have non-compacting embryos with 7-9 cells, under 20% fragmentation. at 66±2 hours after ICSI
Interventions
transfer of 2 utilizable compacting embryos
transfer of 2 utilizable non-compacting embryos have 7-9 cells with under 20% fragmentation.
Eligibility Criteria
You may qualify if:
- IVF treatment for infertility
- Controlled ovarian hyperstimulation by GnRH antagonist protocol.
- IVF cycles ≤2
- Eligible for transfer of 2 embryos on day 3
- Have at least 2 embryos which are 7-9 cells and fragmentation ≤20%, that had either early compaction or still on cleavage stage
You may not qualify if:
- Oocyte donation cycles
- Abnormal uterine
- Using GnRH agonist for triggering.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
My Duc Hospital
Ho Chi Minh City, 70000, Vietnam
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tuong M Ho, MD
CGRH - Vietnam National University
Central Study Contacts
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
Study Record Dates
First Submitted
November 25, 2016
First Posted
December 8, 2016
Study Start
December 1, 2016
Primary Completion
November 1, 2017
Study Completion
December 1, 2017
Last Updated
July 17, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share