Antimullerian Hormone Versus Antral Follicle Count for Determination of Gonadotrophin Dosing in IVF

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomised Trial to Compare Antral Follicle Count and Serum Anti-Mullerian Hormone Level for Determination of Gonadotrophin Dosing in In-vitro Fertilisation

Conditions
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Infertility

Intervention / Treatment
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* Other: Serum AMH measurement
* Other: AFC measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AMH group<br>Serum AMH measurement | Other: Serum AMH measurement<br>* Serum AMH is measured one month before the IVF treatment<br>|
| Sham Comparator: AFC group<br>AFC measurement | Other: AFC measurement<br>* Early follicular phase AFC is measured one month before the IVF treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian response, anti-Mullerian hormone, antral follicle count