NCT03581422

Brief Summary

In recent years, frozen-thawed embryo transfer procedure (FET) has been widely used to increase the cumulative pregnancy rate per IVF-cycle: which is the best preparation protocol remains a matter of debate. A retrospective analysis was conducted between 2012-2017. The aim was comparing clinical pregnancy rate (CPR) of pure natural cycle frozen-thawed embryo transfer (NC-FET) versus natural cycle frozen-thawed embryo transfer with hCG-triggered ovulation (mNC-FET).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,866

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Status
completed

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

January 1, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2015

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 10, 2018

Completed
Last Updated

July 19, 2018

Status Verified

June 1, 2018

Enrollment Period

3.5 years

First QC Date

June 26, 2018

Last Update Submit

July 17, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • CPR in NCFET vs mNCFET

    compare the effectiveness in terms of better clinical pregnancy rates (CPR) of pure natural cycle frozen-thawed embryo transfer (NC-FET) versus natural cycle frozen-thawed embryo transfer modified by HCG administration

    2012-2017

Study Arms (2)

NC-FET

pure natural cycle frozen-thawed embryo transfer

mNC-FET

modified natural cycle frozen-thawed embryo transfer by hCG administration

Drug: hCG administration before embryo transfer

Interventions

Thawed embryo transfer with ovulation triggered by hCG

Also known as: Gonasi HP 5000 UI or Ovitrelle 250mg
mNC-FET

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

2866 cycles were included in the analysis. To limit potential confounders, only single blastocyst transfer cycles were included, vitrified on Days 5 or 6, excluding PGT-a cycles and cleavage stage embryo transfers.

You may qualify if:

  • only single blastocyst transfer cycles were included

You may not qualify if:

  • PGT-a cycles and cleavage stage embryo transfers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Levi Setti PE, Cirillo F, De Cesare R, Morenghi E, Canevisio V, Ronchetti C, Baggiani A, Smeraldi A, Albani E, Patrizio P. Seven Years of Vitrified Blastocyst Transfers: Comparison of 3 Preparation Protocols at a Single ART Center. Front Endocrinol (Lausanne). 2020 May 29;11:346. doi: 10.3389/fendo.2020.00346. eCollection 2020.

MeSH Terms

Interventions

Chorionic Gonadotropin

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteins

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 10, 2018

Study Start

January 1, 2012

Primary Completion

June 15, 2015

Study Completion

December 31, 2017

Last Updated

July 19, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share