AzTrials
AzTrials

SubfertilityNCT02748278

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

An observational study of Subfertility, run by The University of Hong Kong at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 18 to 40 years, women only
Conditions the study is for
Subfertility
What is being tested?
Transvaginal ultrasound-guided oocyte retrieval and Embryo transfer
How many people
192 participants
Where
1 siteChina
Study dates
1 Oct 2016to 30 Dec 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • Women only
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site
  • Department of Obstetrics and Gynaecology

    Hong Kong, Hong Kong

Other trials in China

About this study

Official title: Comparison of the Number of Oocytes Obtained Between Chinese and Caucasian Women Undergoing in Vitro Fertilization Treatment With a Standard Ovarian Stimulation Regimen

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.

Conditions
Subfertility
Being tested
Transvaginal ultrasound-guided oocyte retrieval, Embryo transfer
Keywords
subfertility, In-vitro fertilization
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transvaginal ultrasound-guided oocyte retrievalProcedure or surgery

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

  • Embryo transferProcedure or surgery

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of oocytes obtained

    Number of oocytes obtained

    Measured: 17 days

Secondary outcomes (12)
  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

    Measured: 8 and day of hCG

  2. Duration of recombinant FSH

    Duration of recombinant FSH

    Measured: 15 days

  3. Dosage of recombinant FSH

    Dosage of recombinant FSH

    Measured: 15 days

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

    Serum estradiol levels on day 9 and day of hCG

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 9 and day of hCG

  8. Miscarriage rate

    Miscarriage rate

    Measured: 24 weeks

  9. Clinical pregnancy rate

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

    Measured: 6 weeks

  10. Ongoing pregnancy rate

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

    Measured: 12 weeks

  11. Live birth rate

    Live birth rate

    Measured: 44 weeks

  12. Ovarian hyperstimulation rate

    Ovarian hyperstimulation rate (according to RCOG guideline)

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2016 (estimated)
  2. Study start1 Oct 2016
  3. Primary completion30 Apr 2020
  4. Study completion30 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02748278
Sponsor's protocol ID
UW 15-547
Status last verified
Jul 2020
First submitted
13 Apr 2016
Last updated
29 Apr 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

An observational study of Subfertility, run by The University of Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of oocytes obtained (time frame: 17 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02748278, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in