Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2026-01-01 @ 11:13 AM
Study NCT ID:
NCT02739269
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2016-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Antimullerian Hormone Versus Antral Follicle Count for Determination of Gonadotrophin Dosing in IVF
Sponsor:
The University of Hong Kong
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: