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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMH group | Active Comparator | Serum AMH measurement |
|
| AFC group | Sham Comparator | AFC measurement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Serum AMH measurement | Other | Serum AMH is measured one month before the IVF treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Having Desired Ovarian Response | Percentage of subjects with number of oocytes retrieved being between 6 and14 | One single time point, i.e. at the time of oocyte retrieval |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8th day of ovarian stimulation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hang Wun Raymond Li, MBBS, FRCOG | The University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Hong Kong | Hong Kong |
No such plan at the moment
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A total of 200 women who were undergoing in vitro fertilisation treatment in Queen Mary Hospital, Hong Kong, were recruited.
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| ID | Title | Description |
|---|---|---|
| FG000 | AMH Group | Serum AMH measurement Gonadotrophin dosing was based on serum AMH measured one month before the IVF treatment |
| FG001 | AFC Group | AFC measurement Gonadotrophin dosing was based on early follicular phase AFC measured one month before the IVF treatment |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AMH Group | Serum AMH measurement Serum AMH measurement: Serum AMH is measured one month before the IVF treatment |
| BG001 | AFC Group | AFC measurement AFC measurement: Early follicular phase AFC is measured one month before the IVF treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Subjects Having Desired Ovarian Response | Percentage of subjects with number of oocytes retrieved being between 6 and14 | Intention-to-treat basis. Those not proceeding with ovarian stimulation or oocyte retrieval were regarded as not having desired ovarian response | Posted | Count of Participants | Participants | One single time point, i.e. at the time of oocyte retrieval |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AMH Group | Serum AMH measurement Gonadotrophin dosing was based on serum AMH measured one month before the IVF treatment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Raymond Li | The University of Hong Kong | +852 22554517 | raymondli@hku.hk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 29, 2016 | May 18, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| AFC measurement |
| Other |
Early follicular phase AFC is measured one month before the IVF treatment |
|
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 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 | Intention-to-treat analysis. Two subjects in the AFC group did not proceed with treatment and were regarded as not requiring dosage adjustment. | Posted | Count of Participants | Participants | 8th day of ovarian stimulation |
|
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | AFC Group | AFC measurement Gonadotrophin dosing was based on early follicular phase AFC measured one month before the IVF treatment | 0 | 100 | 0 | 100 | 0 | 100 |
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