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

• Sponsor: The University of Hong Kong (Other)
• Overall Status: Completed
• CT.gov ID: NCT02739269
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Actual Duration (Months): 24.4
• Patients Per Site Per Month: 8.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Other: Serum AMH measurement; Other: AFC measurement	N/A

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.

Study Design

• Study Type: Interventional
• 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: Apr 7, 2016
• Actual Primary Completion Date: Apr 20, 2018
• Actual Study Completion Date: Apr 20, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects Having Desired Ovarian Response [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queen Mary Hospital	Hong Kong		Hong Kong

Sponsors and Collaborators

• The University of Hong Kong

Investigators

• Principal Investigator: Hang Wun Raymond Li, MBBS, FRCOG, The University of Hong Kong

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 29, 2016

More Information

Publications

None provided.

• 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: Apr 15, 2016
• Last Update Posted: Feb 27, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Keywords provided by Dr. Hang Wun Raymond Li, Associate Professor, The University of Hong Kong: ovarian response; anti-Mullerian hormone; antral follicle count
• Additional relevant MeSH terms: Infertility

Study Results

Participant Flow

Recruitment Details	A total of 200 women who were undergoing in vitro fertilisation treatment in Queen Mary Hospital, Hong Kong, were recruited.

Arm/Group Title	AMH Group	AFC Group
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

Baseline Characteristics

Arm/Group Title	AMH Group	AFC Group	Total
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 Participants	100	100	200
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	36	35	35
Sex: Female, Male (Count of Participants)
Female	100 100%	100 100%	200 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	100 100%	100 100%	200 100%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Hong Kong	100 100%	100 100%	200 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

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
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
Measure Participants	100	100
Count of Participants [Participants]	49 49%	54 54%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AMH Group, AFC Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.479
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

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

Outcome Measure Data

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
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
Measure Participants	100	100
Count of Participants [Participants]	44 44%	36 36%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	AMH Group, AFC Group
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	1 month
Arm/Group Title	AMH Group		AFC Group
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/100 (0%)
Serious Adverse Events
	AMH Group		AFC Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/100 (0%)
Other (Not Including Serious) Adverse Events
	AMH Group		AFC Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/100 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.