InfertilityPhase 4NCT01783301
Anti-Mullerian Hormone (AMH) Versus Antral Follicle Count (AFC) Guided rFSH Dosing Study
A Phase 4 study testing FSH in people with Infertility, run by Vietnam National University at 1 site in Vietnam.
Trial summary
The overall objectives of this trial are to: To explore the efficacy and safety of using either antral follicle count (AFC) or anti-Mullerian hormone (AMH) to guide the starting dose of GONAL-f® in ovarian stimulation for Assisted Reproductive Technology (ART). Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- FSH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteVietnam
- Study dates
- Oct 2011to Dec 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Starting a treatment with GONAL-f® according to the decision of the investigator and in accordance with the indication and dosing recommendation
- Age < 40 years at the time of GONAL-f® dosing
- BMI < 28 kg/m2
- An early follicular phase (Day 2-4) serum levels of basal FSH ≤12 IU/L measured in the site's own laboratory and taken within 2 months prior to down-regulation start
- Receiving long Gonadotropin-Releasing Hormone (GnRH) agonist protocol (starting on day 21 of preceding cycle until day of hCG)
- Agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
- Have given written informed consent with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.
Who cannot join
- Simultaneous participation in an interventional clinical trial.
- Concommitant use of either Luteinizing Hormone or human menopausal gonadotropin/urinary FSH preparations in study cycle
Trial locations and contacts
1 site in 1 country.
Vietnam1 site
Research Center for Genetics and Reproductive Health
Ho Chi Minh City, Ho Chi Minh
About this study
Official title: A Phase IV, Open-label 2 Arm Trial to Compare the Efficacy and Safety of a Pre-defined Dose of GONAL-f® Based on Antral Follicle Count [Follicles ≥2mm - <11mm]), or AMH for Ovarian Stimulation in Subjects Undergoing Assisted Reproductive Technology (ART) Treatment.
The overall objectives of this trial are to:
- To explore the efficacy and safety of using either antral follicle count (AFC) or anti-Mullerian hormone (AMH) to guide the starting dose of GONAL-f® in ovarian stimulation for Assisted Reproductive Technology (ART).
- To assess the differences in both ovarian response and clinical pregnancy rate between subjects with different AFC and AMH levels undergoing ART.
Read the detailed description
Trial design
This trial is a prospective, Phase IV 2 arm trial exploring the efficacy and safety of using either AFC or AMH to guide the starting GONAL-f® dose for the stimulation treatment of subjects undergoing ART.
Throughout the trial period and before the start of a routine ART cycle, investigators will propose the trial to their potential subjects. All subjects who agree to participate in the trial must sign a consent form, irrespective of whether or not they ultimately agree to have their dose determined by the study protocol. Eligible subjects will be randomised in blocks of 4 at each site via a computer generated random number list to either the AFC guided arm (control) or the AMH guided arm (treatment). The starting doses of GONAL-f® for each arm will be based on the study algorithms, using AFC or AMH guidance.
The investigator will then enter initiate ovarian stimulation with an individualised GONAL-f® dose for that specific subject. This will be maintained for the first 5 days of stimulation after which the dose can be modified based on investigator decision and in accordance with the site's routine clinical practice.
Trial Population
Female partners of infertile couples requiring Assisted Reproductive Technology (ART) treatment.
Data Analysis and Statistics
The primary end-point proportion of patients with desired number of retrieved oocytes (8-12) will be compared between the 2 arms using the chi -square test. The null hypothesis will be that there is no difference between the 2 arms in primary end-point, with the p level set at p=0.05. The secondary end-points will also be compared between the 2 arms using either the Student's t test or anova test.
- Conditions
- Infertility
- Being tested
- FSH
- Keywords
- follicle stimulating hormone, ovarian stimulation, antimullerian hormone, antral follicle count, assisted reproductive technologies
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FSHDrug
Also called GONAL-f
| Study group | Role | What they receive |
|---|---|---|
| Antral follicle count | Active comparator | Start dose of recombinant Follicle-Stimulating Hormone (rFSH) based on AFC guide
* AFC < 6 on both ovary: 375 IU FSH
* 6<AFC <=15 on both ovary: 225 IU FSH
* AFC> 15 on both ovary: 150 IU FSH Receives: Drug: FSH |
| Anti-Mullerian Hormone | Active comparator | Start dose of FSH based on AMH guide
* AMH < 5 pmol/L or < 0.7ng/ml: 375 IU FSH
* AMH 5 to < 15 pmol/L or 0.7 to 2.1ng/ml: 225 IU FSH
* AMH ≥ 15 pmol/L or > 2.1ng/ml: 150 IU FSH Receives: Drug: FSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes retrieved
Measured: 30 minutes after oocyte retrieval completed
Secondary outcomes (1)
Symptoms of ovarian hyperstimulation syndrome (OHSS)
Measured: in 10 days after hCG injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startOct 2011
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vietnam National University
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Serono Vietnam
- Responsible party
- Principal investigator, Manh Tuong Ho, Vietnam National University
- Investigators
- Tuong M Ho, MD, Principal investigator, Vietnam National University HCMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783301
- Sponsor's protocol ID
- 11/QD-CGRH-NCKH&DT
- Status last verified
- Jan 2013
- First submitted
- 17 Jan 2013
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Open-label 2 Arm Trial to Compare the Efficacy and Safety of a Pre-defined Dose of GONAL-f® Based on Antral Follicle Count [Follicles ≥2mm - <11mm]), or AMH for Ovarian Stimulation in Subjects Undergoing Assisted Reproductive Technology (ART) Treatment.
- ClinicalTrials.gov ID
- NCT01783301
- Acronym / sponsor ID
- 11/QD-CGRH-NCKH&DT
- Conditions
- Infertility
- Keywords
- follicle stimulating hormone, ovarian stimulation, antimullerian hormone, antral follicle count, assisted reproductive technologies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Vietnam National UniversityUniversity, hospital or other
- Collaborators
- Merck Serono Vietnam
- Study start
- Oct 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objectives of this trial are to:
- To explore the efficacy and safety of using either antral follicle count (AFC) or anti-Mullerian hormone (AMH) to guide the starting dose of GONAL-f® in ovarian stimulation for Assisted Reproductive Technology (ART).
- To assess the differences in both ovarian response and clinical pregnancy rate between subjects with different AFC and AMH levels undergoing ART.
Detailed description
Trial design
This trial is a prospective, Phase IV 2 arm trial exploring the efficacy and safety of using either AFC or AMH to guide the starting GONAL-f® dose for the stimulation treatment of subjects undergoing ART.
Throughout the trial period and before the start of a routine ART cycle, investigators will propose the trial to their potential subjects. All subjects who agree to participate in the trial must sign a consent form, irrespective of whether or not they ultimately agree to have their dose determined by the study protocol. Eligible subjects will be randomised in blocks of 4 at each site via a computer generated random number list to either the AFC guided arm (control) or the AMH guided arm (treatment). The starting doses of GONAL-f® for each arm will be based on the study algorithms, using AFC or AMH guidance.
The investigator will then enter initiate ovarian stimulation with an individualised GONAL-f® dose for that specific subject. This will be maintained for the first 5 days of stimulation after which the dose can be modified based on investigator decision and in accordance with the site's routine clinical practice.
Trial Population
Female partners of infertile couples requiring Assisted Reproductive Technology (ART) treatment.
Data Analysis and Statistics
The primary end-point proportion of patients with desired number of retrieved oocytes (8-12) will be compared between the 2 arms using the chi -square test. The null hypothesis will be that there is no difference between the 2 arms in primary end-point, with the p level set at p=0.05. The secondary end-points will also be compared between the 2 arms using either the Student's t test or anova test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antral follicle count | Active comparator | Drug: FSHStart dose of recombinant Follicle-Stimulating Hormone (rFSH) based on AFC guide * AFC < 6 on both ovary: 375 IU FSH * 6<AFC <=15 on both ovary: 225 IU FSH * AFC> 15 on both ovary: 150 IU FSH |
| Anti-Mullerian Hormone | Active comparator | Drug: FSHStart dose of FSH based on AMH guide * AMH < 5 pmol/L or < 0.7ng/ml: 375 IU FSH * AMH 5 to < 15 pmol/L or 0.7 to 2.1ng/ml: 225 IU FSH * AMH ≥ 15 pmol/L or > 2.1ng/ml: 150 IU FSH |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Starting a treatment with GONAL-f® according to the decision of the investigator and in accordance with the indication and dosing recommendation
- Age < 40 years at the time of GONAL-f® dosing
- BMI < 28 kg/m2
- An early follicular phase (Day 2-4) serum levels of basal FSH ≤12 IU/L measured in the site's own laboratory and taken within 2 months prior to down-regulation start
- Receiving long Gonadotropin-Releasing Hormone (GnRH) agonist protocol (starting on day 21 of preceding cycle until day of hCG)
Key exclusion criteria (2 listed)
- Simultaneous participation in an interventional clinical trial.
- Concommitant use of either Luteinizing Hormone or human menopausal gonadotropin/urinary FSH preparations in study cycle
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 |
|---|---|---|
| FSHAlso: GONAL-f | Drug | Anti-Mullerian Hormone, Antral follicle count |
Primary outcome
Number of oocytes retrieved
Time frame: 30 minutes after oocyte retrieval completed
1 secondary outcome
Symptoms of ovarian hyperstimulation syndrome (OHSS)
Time frame: in 10 days after hCG injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
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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.
Tuong M Ho, MD principal investigator
Vietnam National University HCMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing FSH in people with Infertility, run by Vietnam National University at 1 site in Vietnam.
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 7 inclusion and 2 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 4 Feb 2013. 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 Vietnam. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of oocytes retrieved (time frame: 30 minutes after oocyte retrieval completed). 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 4 Feb 2013.