NCT02748278

Brief Summary

IVF is a well-established method to treat various causes of infertility. Some studies have suggested that ethnicity affects the success of IVF. This is a prospective study involving two tertiary IVF units in Hong Kong and Australia. The IVF outcome between Chinese and Caucasians will be compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2016

Longer than P75 for all trials

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

April 13, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

April 29, 2021

Status Verified

July 1, 2020

Enrollment Period

3.6 years

First QC Date

April 13, 2016

Last Update Submit

April 27, 2021

Conditions

Keywords

subfertilityIn-vitro fertilization

Outcome Measures

Primary Outcomes (1)

  • Number of oocytes obtained

    Number of oocytes obtained

    17 days

Secondary Outcomes (12)

  • Number of follicles smaller than 14, 16mm and larger than 18mm in diameter on day 8 and day of hCG

    8 and day of hCG

  • Duration of recombinant FSH

    15 days

  • Dosage of recombinant FSH

    15 days

  • Serum estradiol levels on day 9 and day of hCG

    9 and day of hCG

  • Serum FSH levels on day 9 and day of hCG

    9 and day of hCG

  • +7 more secondary outcomes

Interventions

Transvaginal ultrasound-guided oocyte retrieval will be performed 34-36 hours after hCG injection.

One or two embryos will be replaced on day 2-5 after oocyte retrieval.

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women undergoing IVF or intracytoplasmic sperm injection (ICSI) treatment in the two study sites.

You may qualify if:

  • Women age 18-36 years old
  • Body weight \>60Kg
  • Total antral follicle count \>=7 and ≤ 20 i.e. not poor ovarian reserve based on Bologna criteria
  • Chinese women in the HK centre and Caucasian women (defined as originating from the United Kingdom, Europe or United States of America, excluding the Middle East) in the Australian centre
  • Written informed consent

You may not qualify if:

  • Mixed race/ ethnicity
  • History of ovarian surgery
  • Body mass index \>35 kg/m2
  • \>2 previous stimulated IVF cycles
  • History of ovarian hyperstimulation syndrome in previous stimulated IVF cycles
  • Polycystic ovary syndrome or total antral follicle count \>20

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)

  • Ko JKY, Kan A, Leung P, Lee VCY, Li RHW, Ledger W, Ng EHY. Comparison of the number of oocytes obtained after ovarian stimulation between Chinese and Caucasian women undergoing in vitro fertilization using a standardized stimulation regime. J Ovarian Res. 2021 Dec 11;14(1):175. doi: 10.1186/s13048-021-00928-4.

Biospecimen

Retention: SAMPLES WITH DNA

Blood will be saved for genetic study if there is significant difference in the number of oocytes obtained between Chinese and Caucasian women.

MeSH Terms

Conditions

Infertility

Interventions

Embryo Transfer

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, AssistedReproductive TechniquesTherapeuticsInvestigative Techniques

Study Officials

  • Ernest HY Ng

    Department of Obstetrics and Gynaecology, 6/F, Professorial Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2016

First Posted

April 22, 2016

Study Start

October 1, 2016

Primary Completion

April 30, 2020

Study Completion

December 30, 2020

Last Updated

April 29, 2021

Record last verified: 2020-07

Locations