An interventional study of Serum AMH measurement and AFC measurement in Infertility, sponsored by The University of Hong Kong. Completed at 1 site in Hong Kong. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by The University of Hong Kong · Not applicable, Interventional, and Diagnostic
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.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's enrollment of 200 is above the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.
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Exclusion Criteria:
Serum AMH measurement
Other: Serum AMH measurement
AFC measurement
Other: AFC measurement
Serum AMH is measured one month before the IVF treatment
Early follicular phase AFC is measured one month before the IVF treatment
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
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
A total of 200 women who were undergoing in vitro fertilisation treatment in Queen Mary Hospital, Hong Kong, were recruited.
| Milestone | AMH Group | AFC Group |
|---|---|---|
| Started | 100 | 100 |
| Completed | 93 | 96 |
| Not completed | 7 | 4 |
| Withdrew: Protocol violation | 5 | 0 |
| Withdrew: Cycle cancellation | 2 | 2 |
| Withdrew: Withdrawal by subject | 0 | 2 |
Percentage of subjects with number of oocytes retrieved being between 6 and14
| Participants | AMH Group | AFC Group |
|---|---|---|
| Percentage of Subjects Having Desired Ovarian Response | 49 | 54 |
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
| Participants | AMH Group | AFC Group |
|---|---|---|
| Percentage of Subjects Requiring Step-up or Step-down of Gonadotrophin Dose Upon First Ultrasound Tracking | 44 | 36 |
Collected over 1 month. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AMH Group | 0/100 (0%) | 0/100 (0%) | 0/100 (0%) |
| AFC Group | 0/100 (0%) | 0/100 (0%) | 0/100 (0%) |
| Age, Continuous(years) | AMH Group | AFC Group | Total |
|---|---|---|---|
| Median | 36 (34 to 38) | 35 (33 to 37) | 35 (34 to 38) |
| Sex: Female, Male(Participants) | AMH Group | AFC Group | Total |
|---|---|---|---|
| Female | 100 | 100 | 200 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | AMH Group | AFC Group | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 100 | 100 | 200 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | AMH Group | AFC Group | Total |
|---|---|---|---|
| Hong Kong | 100 | 100 | 200 |
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