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

Subfertility Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02748278
• Other study ID #: UW 15-547
• Status: Completed
• Start date: October 1, 2016
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2020
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: December 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• Subfertility

Intervention

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

Locations

Country	Name	City	State
China	Department of Obstetrics and Gynaecology	Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	The University of New South Wales

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of oocytes obtained	Number of oocytes obtained	17 days
Secondary	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	8 and day of hCG
Secondary	Duration of recombinant FSH	Duration of recombinant FSH	15 days
Secondary	Dosage of recombinant FSH	Dosage of recombinant FSH	15 days
Secondary	Serum estradiol levels on day 9 and day of hCG	Serum estradiol levels on day 9 and day of hCG	9 and day of hCG
Secondary	Serum FSH levels on day 9 and day of hCG	Serum FSH levels on day 9 and day of hCG	9 and day of hCG
Secondary	Serum LH levels on day 9 and day of hCG	Serum LH levels on day 9 and day of hCG	9 and day of hCG
Secondary	Serum progesterone levels on day 9 and day of hCG	Serum progesterone levels on day 9 and day of hCG	9 and day of hCG
Secondary	Miscarriage rate	Miscarriage rate	24 weeks
Secondary	Clinical pregnancy rate	Clinical pregnancy rate: presence of intrauterine gestational sac at 6 weeks	6 weeks
Secondary	Ongoing pregnancy rate	Ongoing pregnancy rate: presence of fetal heart pulsation on transvaginal scan at 12 weeks	12 weeks
Secondary	Live birth rate	Live birth rate	44 weeks
Secondary	Ovarian hyperstimulation rate	Ovarian hyperstimulation rate (according to RCOG guideline)	8 weeks