InfertilityNCT02739269
Antimullerian Hormone Versus Antral Follicle Count for Determination of Gonadotrophin Dosing in IVF
A study testing Serum AMH measurement and AFC measurement in people with Infertility, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Serum AMH measurement and AFC measurement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteHong Kong
- Study dates
- 7 Apr 2016to 20 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects undergoing the first IVF cycle during the study period.
Who cannot join
- Body mass index >=30 kg/m2
- Subjects in repeated IVF cycles
- Subjects undergoing IVF treatment using donor oocytes
- Subjects undergoing pre-implantation genetic diagnosis
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Serum AMH measurement, AFC measurement
- Keywords
- ovarian response, anti-Mullerian hormone, antral follicle count
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum AMH measurementOther
Serum AMH is measured one month before the IVF treatment
AFC measurementOther
Early follicular phase AFC is measured one month before the IVF treatment
| Study group | Role | What they receive |
|---|---|---|
| AMH group | Active comparator | Serum AMH measurement Receives: Other: Serum AMH measurement |
| AFC group | Sham comparator | AFC measurement Receives: Other: AFC measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Having Desired Ovarian Response
Percentage of subjects with number of oocytes retrieved being between 6 and14
Measured: One single time point, i.e. at the time of oocyte retrieval
Secondary outcomes (1)
Percentage of Subjects Requiring Step-up or Step-down of Gonadotrophin Dose Upon First Ultrasound Tracking
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
Measured: 8th day of ovarian stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study start7 Apr 2016
- Primary completion20 Apr 2018
- Study completion20 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Hang Wun Raymond Li, The University of Hong Kong
- Investigators
- Hang Wun Raymond Li, MBBS, FRCOG, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739269
- Sponsor's protocol ID
- UW 12-358
- Status last verified
- Feb 2019
- First submitted
- 4 Apr 2016
- Last updated
- 27 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: No such plan at the moment
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02739269
- Acronym / sponsor ID
- UW 12-358
- Conditions
- Infertility
- Keywords
- ovarian response, anti-Mullerian hormone, antral follicle count
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 7 Apr 2016 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 15 Apr 2016 (estimated)
- Results
- Posted 27 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMH group | Active comparator | Other: Serum AMH measurementSerum AMH measurement |
| AFC group | Sham comparator | Other: AFC measurementAFC measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects undergoing the first IVF cycle during the study period.
Key exclusion criteria (4 listed)
- Body mass index >=30 kg/m2
- Subjects in repeated IVF cycles
- Subjects undergoing IVF treatment using donor oocytes
- Subjects undergoing pre-implantation genetic diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serum AMH measurementSerum AMH is measured one month before the IVF treatment | Other | AMH group |
| AFC measurementEarly follicular phase AFC is measured one month before the IVF treatment | Other | AFC group |
Primary outcome
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
1 secondary outcome
Percentage of Subjects Requiring Step-up or Step-down of Gonadotrophin Dose Upon First Ultrasound Tracking
Time frame: 8th day of ovarian stimulation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. No such plan at the moment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hang Wun Raymond Li, MBBS, FRCOG principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serum AMH measurement and AFC measurement in people with Infertility, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects Having Desired Ovarian Response (time frame: One single time point, i.e. at the time of oocyte retrieval). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.