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OpenTrials
Completed

NCT Number: NCT02739269

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

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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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serum AMH measurement

Other

Serum AMH is measured one month before the IVF treatment

AFC measurement

Other

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

Primary outcomes

  1. Percentage of Subjects Having Desired Ovarian Response

    Time frame: 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 outcomes

  1. Percentage of Subjects Requiring Step-up or Step-down of Gonadotrophin Dose Upon First Ultrasound Tracking

    Time frame: 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

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 15, 2016
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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