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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

Tracking Information
First Submitted Date  ICMJE April 4, 2016
First Posted Date  ICMJE April 15, 2016
Results First Submitted Date  ICMJE May 19, 2018
Results First Posted Date  ICMJE February 27, 2019
Last Update Posted Date February 27, 2019
Actual Study Start Date  ICMJE April 7, 2016
Actual Primary Completion Date April 20, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 12, 2016)
Percentage of subjects having appropriate 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 and15
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2019)
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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 12, 2016)
Percentage of Subjects Requiring Step-up or Step-down of Gonadotrophin Dose Upon First Ultrasound Tracking [ Time Frame: 7th 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antimullerian Hormone Versus Antral Follicle Count for Determination of Gonadotrophin Dosing in IVF
Official Title  ICMJE A Randomised Trial to Compare Antral Follicle Count and Serum Anti-Mullerian Hormone Level for Determination of Gonadotrophin Dosing in In-vitro Fertilisation
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Infertility
Intervention  ICMJE
  • Other: Serum AMH measurement
    Serum AMH is measured one month before the IVF treatment
  • Other: AFC measurement
    Early follicular phase AFC is measured one month before the IVF treatment
Study Arms  ICMJE
  • Active Comparator: AMH group
    Serum AMH measurement
    Intervention: Other: Serum AMH measurement
  • Sham Comparator: AFC group
    AFC measurement
    Intervention: Other: AFC measurement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2016)
200
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 20, 2018
Actual Primary Completion Date April 20, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02739269
Other Study ID Numbers  ICMJE UW 12-358
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: No such plan at the moment
Responsible Party Dr. Hang Wun Raymond Li, The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Hang Wun Raymond Li, MBBS, FRCOG The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP