The Number of Blastocysts Formed in the Outcome of Freeze All Strategy: COMFFETI Trial, Cumulative Delivery Rate
The Impact of Blastulation Rate in the Outcome of Freeze All Strategy: COMFFETI Trial, Cumulative Delivery Rate
1 other identifier
observational
160
1 country
1
Brief Summary
A prospective study of the blastulation rate in the outcome of the Freeze all strategy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2013
Longer than P75 for all trials
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
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 2, 2018
CompletedFirst Posted
Study publicly available on registry
March 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2021
CompletedOctober 8, 2020
October 1, 2020
8.2 years
March 2, 2018
October 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cumulative Live Birth rate according to blastulation rate
Cumulative Live Birth rate according to blastulation rate
5 days of embryo culture
Secondary Outcomes (1)
Cumulative Pregnancy rate according to blastulation rate
5 days of embryo culture
Study Arms (3)
0-4 blastocysts
group A: cumulative pregnancy rate of 0-4 blastocysts vitrified
5-7 blastocysts
group B: cumulative pregnancy rate of 5-7 blastocysts vitrified
>7 blastocysts
group C: cumulative pregnancy rate of \>7 blastocysts vitrified
Interventions
The pregnancy and live birth rate according to number of blastocysts formed in our three groups
Eligibility Criteria
Women aged 20-39 years old following blastocyst culture after ICSI cycle in Freeze all Strategy
You may qualify if:
- primary infertility
- age 20-39 years;
- body mass index (BMI) 18-29kg/m2;
- regular menstrual cycle of 26-35days,
- presumed to be ovulatory;
- \>1mil/ml spermatozoa;
- short antagonist protocol
You may not qualify if:
- poor responders;
- age ≥40;
- TESE sperm;
- PGS cycles;
- donor oocytes;
- donor sperm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assisting Naturelead
Study Sites (1)
Assisting Nature
Thessaloniki, 57001, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evangelos Papanikolaou, MD, PhD
Assisting Nature
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2018
First Posted
March 13, 2018
Study Start
November 1, 2013
Primary Completion
December 31, 2021
Study Completion
December 31, 2021
Last Updated
October 8, 2020
Record last verified: 2020-10