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

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ClinicalTrials.gov Identifier: NCT02748278
Recruitment Status : Recruiting
First Posted : April 22, 2016
Last Update Posted : October 11, 2018
Sponsor:
Collaborator:
The University of New South Wales
Information provided by (Responsible Party):
The University of Hong Kong

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.

Condition or disease Intervention/treatment
Subfertility Procedure: Transvaginal ultrasound-guided oocyte retrieval Procedure: Embryo transfer

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 Type : Observational
Estimated Enrollment : 192 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
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
Study Start Date : May 2016
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : August 2019

Intervention Details:
  • Procedure: Transvaginal ultrasound-guided oocyte retrieval
    Transvaginal ultrasound-guided oocyte retrieval will be performed 34-36 hours after hCG injection.
  • Procedure: Embryo transfer
    One or two embryos will be replaced on day 2-5 after oocyte retrieval.


Primary Outcome Measures :
  1. Number of oocytes obtained [ Time Frame: 17 days ]
    Number of oocytes obtained


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

  2. Duration of recombinant FSH [ Time Frame: 15 days ]
    Duration of recombinant FSH

  3. Dosage of recombinant FSH [ Time Frame: 15 days ]
    Dosage of recombinant FSH

  4. Serum estradiol levels on day 9 and day of hCG [ Time Frame: 9 and day of hCG ]
    Serum estradiol levels on day 9 and day of hCG

  5. Serum FSH 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

  6. Serum LH 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

  7. Serum progesterone 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

  8. Miscarriage rate [ Time Frame: 24 weeks ]
    Miscarriage rate

  9. Clinical pregnancy rate [ Time Frame: 6 weeks ]
    Clinical pregnancy rate: presence of intrauterine gestational sac at 6 weeks

  10. Ongoing pregnancy rate [ Time Frame: 12 weeks ]
    Ongoing pregnancy rate: presence of fetal heart pulsation on transvaginal scan at 12 weeks

  11. Live birth rate [ Time Frame: 44 weeks ]
    Live birth rate

  12. Ovarian hyperstimulation rate [ Time Frame: 8 weeks ]
    Ovarian hyperstimulation rate (according to RCOG guideline)


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.


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   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.
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748278


Contacts
Contact: Ernest HY Ng 852-22553400 nghye@hku.hk

Locations
China, Hong Kong
Department of Obstetrics and Gynaecology Recruiting
Hong Kong, Hong Kong, China
Contact: Ernest HY NG, MD    852-22553400    nghye@hku.hk   
Principal Investigator: Ernest HY NG, MD         
Sponsors and Collaborators
The University of Hong Kong
The University of New South Wales
Investigators
Principal Investigator: Ernest HY Ng Department of Obstetrics and Gynaecology, 6/F, Professorial Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong

Responsible Party: The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02748278     History of Changes
Other Study ID Numbers: UW 15-547
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by The University of Hong Kong:
subfertility
In-vitro fertilization

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female