NCT02788097

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
2 months until next milestone

Results Posted

Study results publicly available

December 8, 2016

Completed
Last Updated

February 3, 2017

Status Verified

December 1, 2016

Enrollment Period

5 months

First QC Date

May 25, 2016

Results QC Date

October 17, 2016

Last Update Submit

December 9, 2016

Conditions

Keywords

blastocystsprogesteroneimplantationartificial frozen embryo transfer

Outcome Measures

Primary Outcomes (1)

  • Biochemical Pregnancy

    \>30IU/L of serum βhCG on day 14 of cycle

    1 year

Study Arms (2)

Progesterone + 4

EXPERIMENTAL

the transfer of day 5 blastocyst on the 5th day of progesterone supplementation

Procedure: Progesterone supplementation

Progesterone + 5

ACTIVE COMPARATOR

the transfer of day 5 blastocysts on the 6th day of progesterone supplementation

Procedure: Progesterone supplementation

Interventions

artificial frozen embryo transfers

Progesterone + 4Progesterone + 5

Eligibility Criteria

Age19 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Study Sites (1)

Antalya IVF

Antalya, Antalya, 07080, Turkey (Türkiye)

Location

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: 12826330BACKGROUND
  • van 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: 27005893BACKGROUND
  • Alpha 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

Locations