NCT01931384

Brief Summary

A randomised trial on the use of luteal phase support in frozen-thawed embryo transfer cycles. The hypothesis of the study is that the use of luteal phase support with human chorionic gonadotrophin would increase the pregnancy rate in frozen-thawed embryo transfer cycles.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

July 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 29, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 11, 2015

Status Verified

December 1, 2015

Enrollment Period

3.4 years

First QC Date

August 23, 2013

Last Update Submit

December 10, 2015

Conditions

Subfertility

Keywords

Luteal phase supportHuman chorionic gonadotrophinfrozen-thawed embryo transfer cycle

Outcome Measures

Primary Outcomes (1)

  • ongoing pregnancy rate

    ongoing pregnancy rate which is defined as the number of on-going pregnancies beyond 10-12 weeks gestation per transfer cycle

    4 months

Secondary Outcomes (1)

  • Rate of pregnancy loss per number of transfer cycles

    4 months

Other Outcomes (2)

  • Implantation rate

    4 months

  • Hormonal profile

    2 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

luteal phase support using Human chorionic gonadotrophin 1500 IU intramuscular injection will be given on the day of FET and 6 days later.

Drug: Human chorionic gonadotrophin

control group

PLACEBO COMPARATOR

normal saline (placebo) intramuscular injection will be given on the day of FET and 6 days later

Drug: Placebo

Interventions

Human chorionic gonadotrophinDRUG

luteal phase support using Human chorionic gonadotrophin 1500 IU intramuscular injection will be given on the day of FET and 6 days later.

Intervention group
PlaceboDRUG

Normal saline intramuscularly on the day of embryo transfer and 5 days after embryo transfer.

Also known as: Normal saline
control group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Normal uterine cavity shown on pelvic scanning during the stimulated IVF cycle
  • Endometrial thickness \>=8mm in FET cycles

You may not qualify if:

  • Subjects requiring clomid-induced cycles and hormonal replacement (HRT) cycles
  • History of previous FET cycles within the study period
  • Blastocyst transfer
  • Use of donor oocytes
  • Presence of hydrosalpinx not corrected surgically prior to FET
  • Refusal to join the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (1)

  • Lee VCY, Li RHW, Yeung WSB, Pak Chung HO, Ng EHY. A randomized double-blinded controlled trial of hCG as luteal phase support in natural cycle frozen embryo transfer. Hum Reprod. 2017 May 1;32(5):1130-1137. doi: 10.1093/humrep/dex049.

    PMID: 28333292DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Chorionic GonadotropinSaline Solution

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Vivian Chi Yan Lee, MBBS

    HKU / QMH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2013

First Posted

August 29, 2013

Study Start

July 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

December 11, 2015

Record last verified: 2015-12

Locations

HK(1)