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CompletedNCT02748278Updated Apr 29, 2021

Comparison of the Number of Oocytes Obtained Between Chinese and Caucasian Women in IVF Treatment

An observational study in Subfertility, sponsored by The University of Hong Kong. Completed at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-04-29.

Sponsored by The University of Hong Kong · Observational

Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
192
Ages
18 Years to 40 Years
Sex
Female
01

Study 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.

Read the detailed description

This is a prospective study conducted in two tertiary IVF units in Hong Kong and Australia.

The target population for the trial will be women undergoing IVF or intracytoplasmic sperm injection (ICSI) treatment in two IVF Units.

Intervention:

Patients recruited in this study will undergo IVF+/-ICSI treatment. They will undergo an ultrasound scan on the second or third day (day 2 or 3) of a period to exclude the presence of ovarian cyst and have the antral follicle count determined, which includes all follicles of 2-10 mm measured with a 5.5-7.5mHz transvaginal ultrasound probe. Blood will be checked for anti-mullerian hormone (AMH) measured by Beckman-Coulter Diagnostics.

Ovarian stimulation will be started if there are no ovarian cysts on ultrasound scan. They will receive one long acting gonadotrophin injection Elonva 150 microgram subcutaneously followed by daily gonadotrophin injections (Puregon) 200 IU in an antagonist protocol. Antagonist (orgalutran 0.25 mg) will be started on day 5 of ovarian stimulation. Transvaginal ultrasound will be performed for follicular tracking 7 days after the Elonva injection and every 1-3 days thereafter. No adjustment in FSH dose is allowed. Cycles will be cancelled if there are less than 3 follicles larger than 18mm after one week of 200 IU Puregon or there no developing follicle (i.e. larger than 11mm) after one week of 200 IU Puregon.

Recombinant hCG (Ovidrel, Serono, Bari, Italy) 0.25mg will be given if there are 2 follicles >18 mm in diameter. Gonadotrophin injection will not be given on the day of hCG. Agonist trigger will be used if oestradiol concentration on the day of trigger is greater than 15,000 pmol/L or there are more than 15 follicles >16mm on transvaginal scanning. All embryos or blastocysts will be frozen for transfer later following agonist trigger or when the number of oocytes aspirated is 20 or more. Serum FSH, oestradiol, LH and progesterone concentrations are taken 7 days after the Elonva injection and hCG trigger day. Transvaginal ultrasound-guided oocyte retrieval (TUGOR) will be scheduled on Mondays, Wednesdays and Fridays, 34-36 hours after the hCG injection. Flushing of follicles will not be performed. Follicular fluid not contaminated with blood will be collected from the first and largest follicle on each side for estradiol and progesterone level.

The retrieved oocyte will be inseminated conventionally or by ICSI, depending on the semen parameters. ICSI is advised if the total motile sperm number after sperm preparation \< 0.2 million, sperm morphology by strict criteria \< 3% or fertilization rate \< 30% in previous IVF cycles with conventional insemination. One to two embryos will be replaced on day 2-5 after oocyte retrieval. Luteal phase support will be started according to the standard protocol of the centre. Patients will be followed up for urinary pregnancy test 16 days after embryo transfer. Patients with a positive pregnancy test will have transvaginal ultrasound scan performed 10-14 days later and are referred for antenatal care at 8-10 weeks gestation. The remaining embryos will be frozen. Pregnancy outcome will be monitored.

02

Conditions studied

  • Subfertility

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Keywords

  • subfertility
  • In-vitro fertilization
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 192 is close to the median of 200 across 714 observational studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
192 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • ProcedureTransvaginal ultrasound-guided oocyte retrieval

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

  • ProcedureEmbryo transfer

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

06

What researchers measure

Primary outcomes

  1. Number of oocytes obtained

    Number of oocytes obtained

    Time frame: 17 days

Secondary outcomes

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

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

    Time frame: 8 and day of hCG

  2. Duration of recombinant FSH

    Duration of recombinant FSH

    Time frame: 15 days

  3. Dosage of recombinant FSH

    Dosage of recombinant FSH

    Time frame: 15 days

  4. Serum estradiol levels on day 9 and day of hCG

    Serum estradiol levels on day 9 and day of hCG

    Time frame: 9 and day of hCG

  5. Serum FSH levels on day 9 and day of hCG

    Serum FSH levels on day 9 and day of hCG

    Time frame: 9 and day of hCG

  6. Serum LH levels on day 9 and day of hCG

    Serum LH levels on day 9 and day of hCG

    Time frame: 9 and day of hCG

  7. Serum progesterone levels on day 9 and day of hCG

    Serum progesterone levels on day 9 and day of hCG

    Time frame: 9 and day of hCG

  8. Miscarriage rate

    Miscarriage rate

    Time frame: 24 weeks

  9. Clinical pregnancy rate

    Clinical pregnancy rate: presence of intrauterine gestational sac at 6 weeks

    Time frame: 6 weeks

  10. Ongoing pregnancy rate

    Ongoing pregnancy rate: presence of fetal heart pulsation on transvaginal scan at 12 weeks

    Time frame: 12 weeks

  11. Live birth rate

    Live birth rate

    Time frame: 44 weeks

  12. Ovarian hyperstimulation rate

    Ovarian hyperstimulation rate (according to RCOG guideline)

    Time frame: 8 weeks

07

Study locations

1 site
  • Department of Obstetrics and Gynaecology
    Hong Kong, Hong Kong, China
08

References and documents

Publications

  • 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. PubMed 34895264 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02748278
Lead sponsor
The University of Hong Kong
Collaborators
The University of New South Wales
Responsible party
Sponsor
First posted
Apr 22, 2016
Start date
Oct 1, 2016
Primary completion
Apr 30, 2020
Completion
Dec 30, 2020
Last update
Apr 29, 2021

Study contacts

Ernest HY Ng
principal investigator · Department of Obstetrics and Gynaecology, 6/F, Professorial Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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