NCT02570386

Brief Summary

The objective of the present randomized controlled study is to compare clinical effectiveness and safety of freezing all embryos followed by frozen-thawed embryo transfer (FET) compared to fresh embryo transfer, in women undergoing IVF treatment.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2015

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

April 18, 2019

Status Verified

April 1, 2019

Enrollment Period

3.2 years

First QC Date

September 29, 2015

Last Update Submit

April 16, 2019

Conditions

Subfertility

Keywords

In-vitro fertilizationfrozen thawed embryo transferfresh embryo transfer

Outcome Measures

Primary Outcomes (1)

  • Live birth rate

    A baby born alive after 20 weeks gestation

    up to 24 weeks

Secondary Outcomes (6)

  • Miscarriage rate

    up to 24 weeks

  • Clinical pregnancy rates

    up to 24 weeks

  • Ovarian hyperstimulation rate

    about 1 month

  • Failure of embryos to survive after thawing (per embryo thawed)

    around 6 months

  • Cumulative live birth within 6 months of ovarian stimulation

    up to 24 weeks

  • +1 more secondary outcomes

Study Arms (2)

Control arm

ACTIVE COMPARATOR

Women allocated to the control arm will either undergo fresh embryo transfer at cleavage stage or extended culture and transfer at blastocyst stage according to local policy. A maximum of 2 embryos or blastocysts will be replaced according to the standard protocol under transabdominal ultrasound guidance. Luteal phase support is given according to local protocols.

Procedure: Fresh embryo transfer

Intervention arm

ACTIVE COMPARATOR

Fresh embryo transfer will not be undertaken in this group. Embryos will be frozen by vitrification or slow freezing at cleavage or blastocyst stage according to standard agreed local protocols. Women will be contacted after 4 weeks and arrangements made for frozen embryo transfer.

Procedure: Frozen embryo transfer

Interventions

Fresh embryo transferPROCEDURE

Women allocated to the control arm will either undergo embryo transfer at cleavage stage or extended culture and transfer at blastocyst stage according to local policy. A maximum of 2 embryos or blastocysts will be replaced according to the standard protocol under transabdominal ultrasound guidance. Luteal phase support is given according to local protocols.

Control arm
Frozen embryo transferPROCEDURE

Fresh embryo transfer will not be undertaken. Embryos will be frozen by vitrification or slow freezing at cleavage or blastocyst stage according to standard agreed local protocols. Women will be contacted after 4 weeks and arrangements made for frozen embryo transfer.

Intervention arm

Eligibility Criteria

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

You may qualify if:

  • Women under 42 years of age
  • Presence of at least 3 embryos suitable to freeze on day 2 or 3 following fertilisation based on the centre's criteria
  • Written informed consent

You may not qualify if:

  • Women using donor eggs/donor sperm
  • Women undergoing preimplantation genetic diagnosis
  • Women with abnormal uterine cavity shown on hysterosalpingogram or saline infusion sonogram
  • Women with hydrosalpinges shown on scanning and not corrected treated
  • Women with excessive ovarian response at risk of ovarian hyperstimulation where elective freeze is already planned
  • Women with serum progesterone level on day of human chorionic gonadotrophin\>1.5ng/ml or 5 nmol/L
  • Women whose embryos have not survived freeze-thawing in the past
  • Fresh transfer is planned e.g. patients with endometriosis or adenomyosis who have received prolonged downregulation
  • Only frozen transfer is planned e.g. patients receiving ovarian stimulation regimens which may have adverse impacts on the endometrium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynaecology

Hong Kong, Hong Kong, China

Location

Related Publications (1)

  • 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

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Ernest HY Ng, MD

    Department of Obstetrics and Gynaecology, The University of Hong Kong

    PRINCIPAL INVESTIGATOR

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

September 29, 2015

First Posted

October 7, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

April 18, 2019

Record last verified: 2019-04

Locations

CN(1)