Study Stopped
Large and sustained difference in pregnancy rate
Comparison of Day 19 and Day 20 Artificial FET
Assessment of Artificial FET Reproductive Outcomes: Transfer of Blastocysts on Progesterone + 4 Versus Progesterone + 5
1 other identifier
interventional
130
1 country
1
Brief Summary
In recent artificial frozen embryo transfers (FET) in which blastocysts vitrified on day 4 of culture and transferred on P+4, with blastocysts traditionally transferred on P+5, a high rate of implantation has been observed. In addition, a greater number of these implantations resulted in clinical pregnancies (i.e., a conceptus with normal fetal heart activity). In this prospective randomised control study, the investigators will investigate whether this increased viability, is due either to embryo quality, endometrial receptivity, or a combination of the two factors by randomizing the transfer of day 5 blastocysts to P+4 or P+5.
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 May 2016
Shorter than P25 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
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 25, 2016
CompletedFirst Posted
Study publicly available on registry
June 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedResults Posted
Study results publicly available
December 8, 2016
CompletedFebruary 3, 2017
December 1, 2016
5 months
May 25, 2016
October 17, 2016
December 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Biochemical Pregnancy
\>30IU/L of serum βhCG on day 14 of cycle
1 year
Study Arms (2)
Progesterone + 4
EXPERIMENTALthe transfer of day 5 blastocyst on the 5th day of progesterone supplementation
Progesterone + 5
ACTIVE COMPARATORthe transfer of day 5 blastocysts on the 6th day of progesterone supplementation
Interventions
artificial frozen embryo transfers
Eligibility Criteria
You may qualify if:
- a freeze-all cycle
You may not qualify if:
- patients who do not consent
- patients who retract their consent
- patients with day 4 blastocysts frozen
- patients with no blastocysts frozen
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Antalya IVFlead
Study Sites (1)
Antalya IVF
Antalya, Antalya, 07080, Turkey (Türkiye)
Related Publications (3)
Fauser BC, Devroey P. Reproductive biology and IVF: ovarian stimulation and luteal phase consequences. Trends Endocrinol Metab. 2003 Jul;14(5):236-42. doi: 10.1016/s1043-2760(03)00075-4.
PMID: 12826330BACKGROUNDvan de Vijver A, Polyzos NP, Van Landuyt L, Mackens S, Stoop D, Camus M, De Vos M, Tournaye H, Blockeel C. What is the optimal duration of progesterone administration before transferring a vitrified-warmed cleavage stage embryo? A randomized controlled trial. Hum Reprod. 2016 May;31(5):1097-104. doi: 10.1093/humrep/dew045. Epub 2016 Mar 22.
PMID: 27005893BACKGROUNDAlpha Scientists in Reproductive Medicine and ESHRE Special Interest Group of Embryology. The Istanbul consensus workshop on embryo assessment: proceedings of an expert meeting. Hum Reprod. 2011 Jun;26(6):1270-83. doi: 10.1093/humrep/der037. Epub 2011 Apr 18.
PMID: 21502182BACKGROUND
Results Point of Contact
- Title
- Kevin Coetzee
- Organization
- Antalya IVF
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Scientific advisor
Study Record Dates
First Submitted
May 25, 2016
First Posted
June 2, 2016
Study Start
May 1, 2016
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
February 3, 2017
Results First Posted
December 8, 2016
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will share
data to be entered