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

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ClinicalTrials.gov Identifier: NCT02739269
Recruitment Status : Completed
First Posted : April 15, 2016
Results First Posted : February 27, 2019
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Hang Wun Raymond Li, 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.


Condition or disease Intervention/treatment Phase
Infertility Other: Serum AMH measurement Other: AFC measurement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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
Actual Study Start Date : April 7, 2016
Actual Primary Completion Date : April 20, 2018
Actual Study Completion Date : April 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
Active Comparator: AMH group
Serum AMH measurement
Other: Serum AMH measurement
Serum AMH is measured one month before the IVF treatment

Sham Comparator: AFC group
AFC measurement
Other: AFC measurement
Early follicular phase AFC is measured one month before the IVF treatment




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739269


Locations
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Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Hang Wun Raymond Li, MBBS, FRCOG The University of Hong Kong
  Study Documents (Full-Text)

Documents provided by Dr. Hang Wun Raymond Li, The University of Hong Kong:
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Responsible Party: Dr. Hang Wun Raymond Li, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02739269    
Other Study ID Numbers: UW 12-358
First Posted: April 15, 2016    Key Record Dates
Results First Posted: February 27, 2019
Last Update Posted: February 27, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: No such plan at the moment
Keywords provided by Dr. Hang Wun Raymond Li, The University of Hong Kong:
ovarian response
anti-Mullerian hormone
antral follicle count
Additional relevant MeSH terms:
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Infertility