Infertility
Conditions
Keywords
ovarian response, anti-Mullerian hormone, antral follicle count
Brief summary
This is a prospective randomized trial to compare the use of AFC and serum AMH as the basis for gonadotrophin dosing in in-vitro fertilization treatment. The hypothesis is that the use of serum AMH as the criterion for determination of gonadotrophin dosing in IVF treatment results in more optimal ovarian response than AFC.
Detailed description
Patients undergoing the first-time IVF treatment cycle using either conventional insemination technique or intracytoplasmic sperm injection at Queen Mary Hospital will be invited to participate in this study. Participating subjects will be randomized into either (i) AFC or (ii) AMH group, where the gonadotrophin dosing will be determined based on the baseline AFC and serum AMH respectively as assessed one month before the IVF treatment. Randomisation will be performed according to a computer-generated list which will be read by an independent research nurse. That research nurse will assign the initial gonadotrophin dose according to the study protocol. In the AFC group, starting dose of gonadotrophin will be determined based on serum AMH concentration as follows: AFC \<= 5: 300 IU daily AFC \>5 and \<=15: 225 IU daily AFC \>15: 150 IU daily In the AMH group, starting dose of gonadotrophin will be determined based on serum AMH concentration as follows: AMH \<= 1.0 ng/ml: 300 IU daily AMH \>1.0 and \<=3.3 ng/ml: 225 IU daily AMH \>3.3 ng/ml: 150 IU daily The clinician and patient will both be blinded to the randomization throughout the course of treatment. The proportion of subjects having appropriate ovarian response, defined as the number of oocytes retrieved being 6 to 14 inclusive, will be compared between the two arms.
Interventions
OTHERSerum AMH measurement
Serum AMH is measured one month before the IVF treatment
OTHERAFC measurement
Early follicular phase AFC is measured one month before the IVF treatment
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects undergoing the first IVF cycle during the study period.
Exclusion criteria
* Body mass index \>=30 kg/m2 * Subjects in repeated IVF cycles * Subjects undergoing IVF treatment using donor oocytes * Subjects undergoing pre-implantation genetic diagnosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Having Desired Ovarian Response | One single time point, i.e. at the time of oocyte retrieval | Percentage of subjects with number of oocytes retrieved being between 6 and14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Requiring Step-up or Step-down of Gonadotrophin Dose Upon First Ultrasound Tracking | 8th day of ovarian stimulation | The dose of gonadotrophin will be adjusted according to the ovarian response: if 5 or less follicles growing beyond 10 mm --\> step up if more than 15 follicles growing beyond 10 mm --\> step down |
Countries
Hong Kong
Participant flow
Recruitment details
A total of 200 women who were undergoing in vitro fertilisation treatment in Queen Mary Hospital, Hong Kong, were recruited.
Participants by arm
| Arm | Count |
|---|---|
| AMH Group Serum AMH measurement
Serum AMH measurement: Serum AMH is measured one month before the IVF treatment | 100 |
| AFC Group AFC measurement
AFC measurement: Early follicular phase AFC is measured one month before the IVF treatment | 100 |
| Total | 200 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Cycle cancellation | 2 | 2 |
| Overall Study | Protocol Violation | 5 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | AMH Group | AFC Group | Total |
|---|---|---|---|
| Age, Continuous | 36 years | 35 years | 35 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 100 Participants | 100 Participants | 200 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Hong Kong | 100 participants | 100 participants | 200 participants |
| Sex: Female, Male Female | 100 Participants | 100 Participants | 200 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 100 | 0 / 100 |
| other Total, other adverse events | 0 / 100 | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 | 0 / 100 |
Outcome results
Primary
Percentage of Subjects Having Desired Ovarian Response
Percentage of subjects with number of oocytes retrieved being between 6 and14
Time frame: One single time point, i.e. at the time of oocyte retrieval
Population: Intention-to-treat basis. Those not proceeding with ovarian stimulation or oocyte retrieval were regarded as not having desired ovarian response
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AMH Group | Percentage of Subjects Having Desired Ovarian Response | 49 Participants |
| AFC Group | Percentage of Subjects Having Desired Ovarian Response | 54 Participants |
p-value: 0.479Chi-squared
Secondary
Percentage of Subjects Requiring Step-up or Step-down of Gonadotrophin Dose Upon First Ultrasound Tracking
The dose of gonadotrophin will be adjusted according to the ovarian response: if 5 or less follicles growing beyond 10 mm --\> step up if more than 15 follicles growing beyond 10 mm --\> step down
Time frame: 8th day of ovarian stimulation
Population: Intention-to-treat analysis. Two subjects in the AFC group did not proceed with treatment and were regarded as not requiring dosage adjustment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| AMH Group | Percentage of Subjects Requiring Step-up or Step-down of Gonadotrophin Dose Upon First Ultrasound Tracking | 44 Participants |
| AFC Group | Percentage of Subjects Requiring Step-up or Step-down of Gonadotrophin Dose Upon First Ultrasound Tracking | 36 Participants |
p-value: 0.002Chi-squared