Clinical trial NCT02739269: Antimullerian Hormone Versus Antral Follicle Count for Determination of Gonadotrophin Dosing in IVF
Official title: A Randomised Trial to Compare Antral Follicle Count and Serum Anti-Mullerian Hormone Level for Determination of Gonadotrophin Dosing in In-vitro Fertilisation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: ovarian response
anti-Mullerian hormone
antral follicle count
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2016-04-15
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Subjects Having Desired Ovarian Response
timeFrame: One single time point, i.e. at the time of oocyte retrieval
Secondary outcomes:
measure: Percentage of Subjects Requiring Step-up or Step-down of Gonadotrophin Dose Upon First Ultrasound Tracking
timeFrame: 8th day of ovarian stimulation
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
Study officials:
affiliation: The University of Hong Kong
name: Hang Wun Raymond Li, MBBS, FRCOG
role: PRINCIPAL_INVESTIGATOR
References: