NCT02471573

Brief Summary

To compare the effectiveness of freeze-all and subsequent frozen embryo transfer (freeze all protocol) with fresh embryo transfer (fresh ET).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
782

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

June 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 15, 2015

Completed
15 days until next milestone

Study Start

First participant enrolled

June 30, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2016

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

September 7, 2017

Status Verified

September 1, 2017

Enrollment Period

10 months

First QC Date

June 11, 2015

Last Update Submit

September 6, 2017

Conditions

Infertility

Keywords

IVFFreeze-allfrozen embryo transferfresh transfer

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy

    Ongoing pregnancy is defined as a pregnancy with at least one positive heart beat beyond 12 weeks of gestation.

    12 weeks of gestation

Secondary Outcomes (4)

  • Clinical pregnancy

    5 weeks after embryo placement

  • Implantation rate

    3 weeks after embryo transferred

  • Multiple pregnancy rate

    5 weeks after embryo placement

  • Live birth

    at the time of delivery

Other Outcomes (18)

  • Ovarian hyperstimulation syndrome (OHSS)

    at 10 days after hCG injection and 14 days after embryo transfer

  • Miscarriage

    at 24 weeks of gestation

  • Ectopic pregnancy

    at 12 weeks of gestation

  • +15 more other outcomes

Study Arms (2)

Freeze-all protocol

ACTIVE COMPARATOR

Embryos are selected for cryopreservation using vitrification technique. Two vitrified embryos will be warmed and transferred in subsequent cycle.

Procedure: Freeze-all protocol

Fresh transfer protocol

ACTIVE COMPARATOR

Two embryos are selected and transferred fresh in the same cycle.

Procedure: Fresh transfer protocol

Interventions

Freeze-all protocolPROCEDURE

Embryos are selected for cryopreservation using vitrification technique. Two vitrified embryos will be warmed and transferred in subsequent cycle.

Freeze-all protocol
Fresh transfer protocolPROCEDURE

Two embryos are selected and transferred fresh in the same cycle.

Fresh transfer protocol

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Undergoing In-vitro fertilization (IVF) treatment
  • Number of previous failed embryo transfers ≤ 2
  • Permanent living in Viet Nam
  • Ovarian hyperstimulation with Gonadotropin releasing hormone (GnRH) antagonist protocol
  • Eligible for embryo transfer (ET) on day 3
  • Having at least one top-quality embryo on day 3.
  • Number of embryos transferred ≤ 2
  • Willing to participate in the study
  • Not to participate in another IVF study at the same time

You may not qualify if:

  • women with polycystic ovary syndrome
  • In vitro maturation (IVM) cycles
  • Oocyte donation cycles
  • Using GnRH agonist for triggering

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

My Duc Hospital, IVFMD

Ho Chi Minh City, Ho Chi Minh, Vietnam

Location

Related Publications (3)

  • Zaat T, Zagers M, Mol F, Goddijn M, van Wely M, Mastenbroek S. Fresh versus frozen embryo transfers in assisted reproduction. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD011184. doi: 10.1002/14651858.CD011184.pub3.

    PMID: 33539543DERIVED

  • Vuong LN, Ly TT, Nguyen NA, Nguyen LMT, Le XTH, Le TK, Le KTQ, Le TV, Nguyen MHN, Dang VQ, Norman RJ, Mol BW, Ho TM. Development of children born from freeze-only versus fresh embryo transfer: follow-up of a randomized controlled trial. Fertil Steril. 2020 Sep;114(3):558-566. doi: 10.1016/j.fertnstert.2020.04.041. Epub 2020 Jun 16.

    PMID: 32560970DERIVED

  • Vuong LN, Dang VQ, Ho TM, Huynh BG, Ha DT, Pham TD, Nguyen LK, Norman RJ, Mol BW. IVF Transfer of Fresh or Frozen Embryos in Women without Polycystic Ovaries. N Engl J Med. 2018 Jan 11;378(2):137-147. doi: 10.1056/NEJMoa1703768.

    PMID: 29320655DERIVED

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Tuong M Ho, MD

    Research Center for Genetics and Reproductive Health, School of Medicine, Vietnam National University HCMC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 11, 2015

First Posted

June 15, 2015

Study Start

June 30, 2015

Primary Completion

April 10, 2016

Study Completion

February 1, 2017

Last Updated

September 7, 2017

Record last verified: 2017-09

Locations

VN(1)