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.
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
- Type of treatment
- Injection or infusion, Surgery or procedure
- 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.
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.
Number of oocytes obtained
Number of oocytes obtained
Measured: 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
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
Duration of recombinant FSH
Duration of recombinant FSH
Measured: 15 days
Dosage of recombinant FSH
Dosage of recombinant FSH
Measured: 15 days
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
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
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
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
Miscarriage rate
Miscarriage rate
Measured: 24 weeks
Clinical pregnancy rate
Clinical pregnancy rate: presence of intrauterine gestational sac at 6 weeks
Measured: 6 weeks
Ongoing pregnancy rate
Ongoing pregnancy rate: presence of fetal heart pulsation on transvaginal scan at 12 weeks
Measured: 12 weeks
Live birth rate
Live birth rate
Measured: 44 weeks
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.
- First posted22 Apr 2016 (estimated)
- Study start1 Oct 2016
- Primary completion30 Apr 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SubfertilityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The University of New South Wales
- Responsible party
- Sponsor
- Investigators
- Ernest HY Ng, Principal investigator, Department of Obstetrics and Gynaecology, 6/F, Professorial Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02748278
- Acronym / sponsor ID
- UW 15-547
- Conditions
- Subfertility
- Keywords
- subfertility, In-vitro fertilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The University of New South Wales
- Study start
- 1 Oct 2016 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women undergoing IVF or intracytoplasmic sperm injection (ICSI) treatment in the two study sites.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvaginal ultrasound-guided oocyte retrievalTransvaginal ultrasound-guided oocyte retrieval will be performed 34-36 hours after hCG injection. | Procedure or surgery | – |
| Embryo transferOne or two embryos will be replaced on day 2-5 after oocyte retrieval. | Procedure or surgery | – |
Primary outcome
Number of oocytes obtained
Time frame: 17 days
Number of oocytes obtained
12 secondary outcomes
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
Duration of recombinant FSH
Time frame: 15 days
Dosage of recombinant FSH
Time frame: 15 days
Serum estradiol levels on day 9 and day of hCG
Time frame: 9 and day of hCG
Serum FSH levels on day 9 and day of hCG
Time frame: 9 and day of hCG
Serum LH levels on day 9 and day of hCG
Time frame: 9 and day of hCG
Serum progesterone levels on day 9 and day of hCG
Time frame: 9 and day of hCG
Miscarriage rate
Time frame: 24 weeks
Clinical pregnancy rate
Time frame: 6 weeks
Ongoing pregnancy rate
Time frame: 12 weeks
Live birth rate
Time frame: 44 weeks
Ovarian hyperstimulation rate
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Derived from this study: PubMed 34895264Ko 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.
- Individual participant dataSharing planned: Undecided
Related trials for Subfertility
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
Not yet recruitingPhase 3
Progesterone Luteal Support in Unexplained Infertility Management
Infertility, Female Infertility
RecruitingObservational study
Assessing the Correlation Between Phospholipase C Zeta Measurements and Semen Parameters
Male Infertility, Male Subfertility
RecruitingPhase 3
GnRH Agonist for Dual Trigger in IVF and for Luteal Phase Support in FET
Subfertility
RecruitingObservational study
The FLORA-project: in Search for the Microbial Cause of Chronic Endometritis and the Most Appropriate Treatment to Obtain a Successful Pregnancy IVF/ICSI
Endometritis; Chronic, Subfertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernest HY Ng principal investigator
Department of Obstetrics and Gynaecology, 6/F, Professorial Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong
1 site in 1 country: see every site and its status.
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.