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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-07

Study Completion Date

2018-04-20

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.

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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.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AMH group

Serum AMH measurement

Group Type ACTIVE_COMPARATOR

Serum AMH measurement

Intervention Type OTHER

Serum AMH is measured one month before the IVF treatment

AFC group

AFC measurement

Group Type SHAM_COMPARATOR

AFC measurement

Intervention Type OTHER

Early follicular phase AFC is measured one month before the IVF treatment

Interventions

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Serum AMH measurement

Serum AMH is measured one month before the IVF treatment

Intervention Type OTHER

AFC measurement

Early follicular phase AFC is measured one month before the IVF treatment

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No