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

The University of Hong Kong (HKU)

Status: Completed

Conditions: Infertility

Treatments: Other: Serum AMH measurement; Other: AFC measurement

Study type: Interventional

Funder types: Other

Identifiers

NCT02739269

UW 12-358

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

AMH group

Active Comparator group

Description:

Serum AMH measurement

Treatment:

Other: Serum AMH measurement

AFC group

Sham Comparator group

Description:

AFC measurement

Treatment:

Other: AFC measurement