Natural Cycle Versus Endometrial Preparation for Healthy Blastocyst Transfer
The Clinical Results After Frozen-thawed Healthy Blastocyst Transfer in Natural Cycle Versus Cycle With Endometrial Preparation
1 other identifier
interventional
236
1 country
2
Brief Summary
This study evaluates the difference in pregnancy rate transferring a healthy blastocyst in natural or artificial cycle.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2015
Shorter than P25 for not_applicable
2 active sites
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
February 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 6, 2015
CompletedFirst Posted
Study publicly available on registry
March 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedJanuary 28, 2016
July 1, 2015
5 months
February 6, 2015
January 27, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
clinical pregnancy rate confirmed by ultrasound evidence of fetal heart activity
12 weeks after embryo transfer
Secondary Outcomes (3)
live-birth rate confirmed by the number of born
term pregnancy delivery
cost-benefit of two endometrial preparation protocol
30 weeks beginning from day 21 of the previous cycle day up to the pregnancy test
The number of patients with the anxiety and depression increase
Six weeks beginning on the day of treatment start, on the day of progesterone administration, on the day of blastocyst transfer and the pregnancy test
Study Arms (2)
natural cycle
OTHERUltrasound controls and endocrine blood test to asses the day of ovulation for embryo transfer
hormonal cycle
ACTIVE COMPARATORUltrasound controls and endocrine blood test to asses the endometrium thickness for embryo transfer
Interventions
healthy blastocyst transfer in natural and hormonal cycle
Eligibility Criteria
You may qualify if:
- frozen-thawed healthy blastocyst
You may not qualify if:
- post thawed not survival healthy blastocyst
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
European Hospital
Rome, RM, 00149, Italy
European Hospital
Rome, Roma, 00149, Italy
Related Publications (1)
Greco E, Litwicka K, Arrivi C, Varricchio MT, Caragia A, Greco A, Minasi MG, Fiorentino F. The endometrial preparation for frozen-thawed euploid blastocyst transfer: a prospective randomized trial comparing clinical results from natural modified cycle and exogenous hormone stimulation with GnRH agonist. J Assist Reprod Genet. 2016 Jul;33(7):873-84. doi: 10.1007/s10815-016-0736-y. Epub 2016 May 24.
PMID: 27221477DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ERmanno Greco, MD
European Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2015
First Posted
March 4, 2015
Study Start
February 1, 2015
Primary Completion
July 1, 2015
Study Completion
September 1, 2015
Last Updated
January 28, 2016
Record last verified: 2015-07