Antimullerian Hormone Versus Antral Follicle Count for Determination of Gonadotrophin Dosing in IVF
A Randomised Trial to Compare Antral Follicle Count and Serum Anti-Mullerian Hormone Level for Determination of Gonadotrophin Dosing in In-vitro Fertilisation
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2016
CompletedStudy Start
First participant enrolled
April 7, 2016
CompletedFirst Posted
Study publicly available on registry
April 15, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2018
CompletedResults Posted
Study results publicly available
February 27, 2019
CompletedFebruary 27, 2019
February 1, 2019
2 years
April 4, 2016
May 19, 2018
February 21, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Subjects Having Desired Ovarian Response
Percentage of subjects with number of oocytes retrieved being between 6 and14
One single time point, i.e. at the time of oocyte retrieval
Secondary Outcomes (1)
Percentage of Subjects Requiring Step-up or Step-down of Gonadotrophin Dose Upon First Ultrasound Tracking
8th day of ovarian stimulation
Study Arms (2)
AMH group
ACTIVE COMPARATORSerum AMH measurement
AFC group
SHAM COMPARATORAFC measurement
Interventions
Early follicular phase AFC is measured one month before the IVF treatment
Eligibility Criteria
You may qualify if:
- Subjects undergoing the first IVF cycle during the study period.
You may not qualify if:
- Body mass index \>=30 kg/m2
- Subjects in repeated IVF cycles
- Subjects undergoing IVF treatment using donor oocytes
- Subjects undergoing pre-implantation genetic diagnosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Mary Hospital
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Raymond Li
- Organization
- The University of Hong Kong
Study Officials
- PRINCIPAL INVESTIGATOR
Hang Wun Raymond Li, MBBS, FRCOG
The University of Hong Kong
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 4, 2016
First Posted
April 15, 2016
Study Start
April 7, 2016
Primary Completion
April 20, 2018
Study Completion
April 20, 2018
Last Updated
February 27, 2019
Results First Posted
February 27, 2019
Record last verified: 2019-02