NCT02378584

Brief Summary

This study evaluates the difference in pregnancy rate transferring a healthy blastocyst in natural or artificial cycle.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
236

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

February 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

January 28, 2016

Status Verified

July 1, 2015

Enrollment Period

5 months

First QC Date

February 6, 2015

Last Update Submit

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

OTHER

Ultrasound controls and endocrine blood test to asses the day of ovulation for embryo transfer

Other: embryo transfer

hormonal cycle

ACTIVE COMPARATOR

Ultrasound controls and endocrine blood test to asses the endometrium thickness for embryo transfer

Other: embryo transfer

Interventions

healthy blastocyst transfer in natural and hormonal cycle

Also known as: drug adminstration, clinical controls
hormonal cyclenatural cycle

Eligibility Criteria

Age20 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

European Hospital

Rome, Roma, 00149, Italy

Location

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.

MeSH Terms

Conditions

Infertility

Interventions

Embryo Transfer

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • ERmanno Greco, MD

    European Hospital

    STUDY DIRECTOR

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

Locations