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

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Other: Serum AMH measurement; Other: AFC measurement

• Registration Number: NCT02739269
• Lead Sponsor: The University of Hong Kong

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-04-04
• Study Start: 2016-04-07
• Study First Submitted QC: 2016-04-12
• Study First Posted: 2016-04-15
• Primary Completion: 2018-04-20
• Study Completion: 2018-04-20
• Results First Submitted: 2018-05-19
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-21
• Last Update Submitted: 2019-02-21
• Results First Posted: 2019-02-27
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Subjects undergoing the first IVF cycle during the study period.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMH group	Serum AMH measurement	Serum AMH measurement
AFC group	AFC measurement	AFC measurement

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects Having Desired Ovarian Response	One single time point, i.e. at the time of oocyte retrieval	Percentage of subjects with number of oocytes retrieved being between 6 and14

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Requiring Step-up or Step-down of Gonadotrophin Dose Upon First Ultrasound Tracking	8th day of ovarian stimulation	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

Trial Locations

Locations (1)

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong