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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Infertility
Interventions Other: Serum AMH measurement
Other: AFC measurement
Enrollment 200
Recruitment Details A total of 200 women who were undergoing in vitro fertilisation treatment in Queen Mary Hospital, Hong Kong, were recruited.
Pre-assignment Details  
Arm/Group Title AMH Group AFC Group
Hide Arm/Group Description

Serum AMH measurement

Gonadotrophin dosing was based on serum AMH measured one month before the IVF treatment

AFC measurement

Gonadotrophin dosing was based on early follicular phase AFC measured one month before the IVF treatment

Period Title: Overall Study
Started 100 100
Completed 93 96
Not Completed 7 4
Reason Not Completed
Protocol Violation             5             0
Cycle cancellation             2             2
Withdrawal by Subject             0             2
Arm/Group Title AMH Group AFC Group Total
Hide Arm/Group Description

Serum AMH measurement

Serum AMH measurement: Serum AMH is measured one month before the IVF treatment

AFC measurement

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

Total of all reporting groups
Overall Number of Baseline Participants 100 100 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 100 participants 100 participants 200 participants
36
(34 to 38)
35
(33 to 37)
35
(34 to 38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Female
100
 100.0%
100
 100.0%
200
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 100 participants 100 participants 200 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
100
 100.0%
100
 100.0%
200
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Hong Kong Number Analyzed 100 participants 100 participants 200 participants
100 100 200
1.Primary Outcome
Title Percentage of Subjects Having Desired Ovarian Response
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat basis. Those not proceeding with ovarian stimulation or oocyte retrieval were regarded as not having desired ovarian response
Arm/Group Title AMH Group AFC Group
Hide Arm/Group Description:

Serum AMH measurement

Gonadotrophin dosing was based on serum AMH measured one month before the IVF treatment

AFC measurement

Gonadotrophin dosing was based on early follicular phase AFC measured one month before the IVF treatment

Overall Number of Participants Analyzed 100 100
Measure Type: Count of Participants
Unit of Measure: Participants
49
  49.0%
54
  54.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AMH Group, AFC Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.479
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Subjects Requiring Step-up or Step-down of Gonadotrophin Dose Upon First Ultrasound Tracking
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat analysis. Two subjects in the AFC group did not proceed with treatment and were regarded as not requiring dosage adjustment.
Arm/Group Title AMH Group AFC Group
Hide Arm/Group Description:

Serum AMH measurement

Gonadotrophin dosing was based on serum AMH measured one month before the IVF treatment

AFC measurement

Gonadotrophin dosing was based on early follicular phase AFC measured one month before the IVF treatment

Overall Number of Participants Analyzed 100 100
Measure Type: Count of Participants
Unit of Measure: Participants
44
  44.0%
36
  36.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AMH Group, AFC Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AMH Group AFC Group
Hide Arm/Group Description

Serum AMH measurement

Gonadotrophin dosing was based on serum AMH measured one month before the IVF treatment

AFC measurement

Gonadotrophin dosing was based on early follicular phase AFC measured one month before the IVF treatment

All-Cause Mortality
AMH Group AFC Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/100 (0.00%) 
Hide Serious Adverse Events
AMH Group AFC Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/100 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AMH Group AFC Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/100 (0.00%)   0/100 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Raymond Li
Organization: The University of Hong Kong
Phone: +852 22554517
EMail: raymondli@hku.hk
Layout table for additonal information
Responsible Party: Dr. Hang Wun Raymond Li, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02739269    
Other Study ID Numbers: UW 12-358
First Submitted: April 4, 2016
First Posted: April 15, 2016
Results First Submitted: May 19, 2018
Results First Posted: February 27, 2019
Last Update Posted: February 27, 2019