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
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||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||April 7, 2016|
|Actual Primary Completion Date :||April 20, 2018|
|Actual Study Completion Date :||April 20, 2018|
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
Other: AFC measurement
Early follicular phase AFC is measured one month before the IVF treatment
- Percentage of Subjects Having Desired Ovarian Response [ Time Frame: One single time point, i.e. at the time of oocyte retrieval ]Percentage of subjects with number of oocytes retrieved being between 6 and14
- Percentage of Subjects Requiring Step-up or Step-down of Gonadotrophin Dose Upon First Ultrasound Tracking [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02739269
|Queen Mary Hospital|
|Hong Kong, Hong Kong|
|Principal Investigator:||Hang Wun Raymond Li, MBBS, FRCOG||The University of Hong Kong|