Trial Outcomes & Findings for Antimullerian Hormone Versus Antral Follicle Count for Determination of Gonadotrophin Dosing in IVF (NCT NCT02739269)

Results Overview

Percentage of subjects with number of oocytes retrieved being between 6 and14

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

200 participants

Primary outcome timeframe

One single time point, i.e. at the time of oocyte retrieval

Results posted on

2019-02-27

Participant Flow

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

Participant milestones

Participant milestones
Measure	AMH Group Serum AMH measurement Gonadotrophin dosing was based on serum AMH measured one month before the IVF treatment	AFC Group AFC measurement Gonadotrophin dosing was based on early follicular phase AFC measured one month before the IVF treatment
Overall Study STARTED	100	100
Overall Study COMPLETED	93	96
Overall Study NOT COMPLETED	7	4

Reasons for withdrawal

Reasons for withdrawal
Measure	AMH Group Serum AMH measurement Gonadotrophin dosing was based on serum AMH measured one month before the IVF treatment	AFC Group AFC measurement Gonadotrophin dosing was based on early follicular phase AFC measured one month before the IVF treatment
Overall Study Protocol Violation	5	0
Overall Study Cycle cancellation	2	2
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AMH Group n=100 Participants Serum AMH measurement Serum AMH measurement: Serum AMH is measured one month before the IVF treatment	AFC Group n=100 Participants AFC measurement AFC measurement: Early follicular phase AFC is measured one month before the IVF treatment	Total n=200 Participants Total of all reporting groups
Age, Continuous	36 years n=5 Participants	35 years n=7 Participants	35 years n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants	100 Participants n=7 Participants	200 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	100 Participants n=5 Participants	100 Participants n=7 Participants	200 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Hong Kong	100 participants n=5 Participants	100 participants n=7 Participants	200 participants n=5 Participants

PRIMARY outcome

Timeframe: One single time point, i.e. at the time of oocyte retrieval

Population: Intention-to-treat basis. Those not proceeding with ovarian stimulation or oocyte retrieval were regarded as not having desired ovarian response

Percentage of subjects with number of oocytes retrieved being between 6 and14

Outcome measures

Outcome measures
Measure	AMH Group n=100 Participants Serum AMH measurement Gonadotrophin dosing was based on serum AMH measured one month before the IVF treatment	AFC Group n=100 Participants AFC measurement Gonadotrophin dosing was based on early follicular phase AFC measured one month before the IVF treatment
Percentage of Subjects Having Desired Ovarian Response	49 Participants	54 Participants

SECONDARY outcome

Timeframe: 8th day of ovarian stimulation

Population: Intention-to-treat analysis. Two subjects in the AFC group did not proceed with treatment and were regarded as not requiring dosage adjustment.

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

Outcome measures

Outcome measures
Measure	AMH Group n=100 Participants Serum AMH measurement Gonadotrophin dosing was based on serum AMH measured one month before the IVF treatment	AFC Group n=100 Participants AFC measurement Gonadotrophin dosing was based on early follicular phase AFC measured one month before the IVF treatment
Percentage of Subjects Requiring Step-up or Step-down of Gonadotrophin Dose Upon First Ultrasound Tracking	44 Participants	36 Participants

Adverse Events

AMH Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

AFC Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Raymond Li

The University of Hong Kong

Phone: +852 22554517

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place