Antimullerian Hormone Versus Antral Follicle Count for Determination of Gonadotrophin Dosing in IVF
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Serum AMH measurement
AFC measurement
Sponsored by
About this trial
This is an interventional diagnostic trial for Infertility focused on measuring ovarian response, anti-Mullerian hormone, antral follicle count
Eligibility 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
Sites / Locations
- Queen Mary Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
AMH group
AFC group
Arm Description
Serum AMH measurement
AFC measurement
Outcomes
Primary Outcome Measures
Percentage of Subjects Having Desired Ovarian Response
Percentage of subjects with number of oocytes retrieved being between 6 and14
Secondary Outcome Measures
Percentage of Subjects Requiring Step-up or Step-down of Gonadotrophin Dose Upon First Ultrasound Tracking
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
Full Information
NCT ID
NCT02739269
First Posted
April 4, 2016
Last Updated
February 21, 2019
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT02739269
Brief Title
Antimullerian Hormone Versus Antral Follicle Count for Determination of Gonadotrophin Dosing in IVF
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 7, 2016 (Actual)
Primary Completion Date
April 20, 2018 (Actual)
Study Completion Date
April 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
ovarian response, anti-Mullerian hormone, antral follicle count
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMH group
Arm Type
Active Comparator
Arm Description
Serum AMH measurement
Arm Title
AFC group
Arm Type
Sham Comparator
Arm Description
AFC measurement
Intervention Type
Other
Intervention Name(s)
Serum AMH measurement
Intervention Description
Serum AMH is measured one month before the IVF treatment
Intervention Type
Other
Intervention Name(s)
AFC measurement
Intervention Description
Early follicular phase AFC is measured one month before the IVF treatment
Primary Outcome Measure Information:
Title
Percentage of Subjects Having Desired Ovarian Response
Description
Percentage of subjects with number of oocytes retrieved being between 6 and14
Time Frame
One single time point, i.e. at the time of oocyte retrieval
Secondary Outcome Measure Information:
Title
Percentage of Subjects Requiring Step-up or Step-down of Gonadotrophin Dose Upon First Ultrasound Tracking
Description
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
Time Frame
8th day of ovarian stimulation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hang Wun Raymond Li, MBBS, FRCOG
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
No such plan at the moment
Learn more about this trial
Antimullerian Hormone Versus Antral Follicle Count for Determination of Gonadotrophin Dosing in IVF
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