InfertilityPhase 4NCT02430740
Tailored Ovarian Stimulation Based on BMI, AMH, AFC
A Phase 4 study testing recFSH in people with Infertility, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The study objective is to develop a tailored based strategy for ovarian stimulation in IVF patients using AMH, BMI, antral follicle count (AFC). 300 patients will be randomized in 2 arms: 1. control group: standard care rec FSH. 2. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- recFSH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2016to Dec 2023
- 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 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- female infertile patients eligible for IVF treatment
Who cannot join
- polycystic ovaries
- untreated thyroid pathology
- hypogonadotropic hypogonadism
- untreaed hyperprolactinemia
- study drug hypersensitivity
- previous OHSS
Show all 9Show fewer
- unilateral ovariectomy
- genital malformation
- BMI>40
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint Luc
Brussels, 1200
Christine Wyns, MD, PhD, 003227649501, christine.wyns@uclouvain.be
Céline Pirard, Md, PhD, 003227649501, celine.pirard@uclouvain.be
About this study
Official title: Multicentric Randomized Controlled Study to Determine a Tailored Strategy for Controlled Ovarian Stimulation in IVF Based on AMH, BMI and AFC
The study objective is to develop a tailored based strategy for ovarian stimulation in IVF patients using AMH, BMI, antral follicle count (AFC).
300 patients will be randomized in 2 arms:
- control group: standard care rec FSH.
- study group: modified dose of Rec FSH based on AFC with a correction factor based on BMI and basal AMH level.
Primary endpoints: number of mature follicles and eggs collected at egg retrieval; amount of rec FSH used.
Secondary endpoints: fertilization rate; cleavage rate; clinical pregnancy rate; inhibin B and AMH levels during ovarian stimulation.
Read the detailed description
The study objective is to develop a tailored based strategy for ovarian stimulation in IVF patients using AMH, BMI, AFC and inhibin B.
300 patients will be stimulated with rec FSH and an antagonist pituitary inhibition protocol, and randomized (at random computer generated numbers) in 2 arms:
- control group: standard care recFSH based on age, basal FSH and AFC.
- study group: modified dose of Rec FSH based on AFC with a correction factor based on BMI and basal AMH level.
FSH administration: 20IU per antral follicle (from 2-5mm) corrected as follows:
Correction factor for
AMH:
<1 pMol/L X4 1-6 pMol/L X2 7-18 pMol/L X1 >18 pMol/L X0.5 BMI 16.5-18.5 X0.75 18.5-25 X1 25-30 X1.25 30-35 X1.5 35-40 X2 Primary endpoints: number of mature follicles and eggs collected at egg retrieval; amount of rec FSH used.
Secondary endpoints: fertilization rate; cleavage rate; clinical pregnancy rate; inhibin B and AMH levels during ovarian stimulation.
- Conditions
- Infertility
- Being tested
- recFSH
- Keywords
- Fertilization in Vitro, antagonist protocol, antral follicle count, Anti-Mullerian Hormone, Reproductive Techniques, Assisted
- Medical subject headings
- Infertility, Helping Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recFSHDrug
Also called Gonal F, Puregon, Fostimon
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | standard care recFSH Receives: Drug: recFSH |
| study group | Experimental | modified dosage of recFSH for controlled ovarian stimulation based on AMH, BMI and AFC Receives: Drug: recFSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of mature follicles
Measured: 2 years
number of oocytes retrieved
Measured: 2 years
rec FSH dose used
Measured: 2 years
Secondary outcomes (5)
fertilization rate
Measured: 2 years
cleavage rate
Measured: 2 years
clinical pregnancy rate
Measured: 2 years
AMH level during stimulation
Measured: 2 years
Inhibin B level during stimulation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startJan 2016
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wyns, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430740
- Sponsor's protocol ID
- AMH1
- Status last verified
- Apr 2023
- First submitted
- 27 Apr 2015
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Randomized Controlled Study to Determine a Tailored Strategy for Controlled Ovarian Stimulation in IVF Based on AMH, BMI and AFC
- ClinicalTrials.gov ID
- NCT02430740
- Acronym / sponsor ID
- AMH1
- Conditions
- Infertility
- Keywords
- Fertilization in Vitro, antagonist protocol, antral follicle count, Anti-Mullerian Hormone, Reproductive Techniques, Assisted
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 30 Apr 2015 (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 study objective is to develop a tailored based strategy for ovarian stimulation in IVF patients using AMH, BMI, antral follicle count (AFC).
300 patients will be randomized in 2 arms:
- control group: standard care rec FSH.
- study group: modified dose of Rec FSH based on AFC with a correction factor based on BMI and basal AMH level.
Primary endpoints: number of mature follicles and eggs collected at egg retrieval; amount of rec FSH used.
Secondary endpoints: fertilization rate; cleavage rate; clinical pregnancy rate; inhibin B and AMH levels during ovarian stimulation.
Detailed description
The study objective is to develop a tailored based strategy for ovarian stimulation in IVF patients using AMH, BMI, AFC and inhibin B.
300 patients will be stimulated with rec FSH and an antagonist pituitary inhibition protocol, and randomized (at random computer generated numbers) in 2 arms:
- control group: standard care recFSH based on age, basal FSH and AFC.
- study group: modified dose of Rec FSH based on AFC with a correction factor based on BMI and basal AMH level.
FSH administration: 20IU per antral follicle (from 2-5mm) corrected as follows:
Correction factor for
AMH:
<1 pMol/L X4 1-6 pMol/L X2 7-18 pMol/L X1 >18 pMol/L X0.5 BMI 16.5-18.5 X0.75 18.5-25 X1 25-30 X1.25 30-35 X1.5 35-40 X2 Primary endpoints: number of mature follicles and eggs collected at egg retrieval; amount of rec FSH used.
Secondary endpoints: fertilization rate; cleavage rate; clinical pregnancy rate; inhibin B and AMH levels during ovarian stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Drug: recFSHstandard care recFSH |
| study group | Experimental | Drug: recFSHmodified dosage of recFSH for controlled ovarian stimulation based on AMH, BMI and AFC |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- female infertile patients eligible for IVF treatment
Key exclusion criteria (9 listed)
- polycystic ovaries
- untreated thyroid pathology
- hypogonadotropic hypogonadism
- untreaed hyperprolactinemia
- study drug hypersensitivity
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 |
|---|---|---|
| recFSHAlso: Gonal F, Puregon, Fostimon | Drug | control group, study group |
Primary outcome
number of mature follicles
Time frame: 2 years
number of oocytes retrieved
Time frame: 2 years
rec FSH dose used
Time frame: 2 years
5 secondary outcomes
fertilization rate
Time frame: 2 years
cleavage rate
Time frame: 2 years
clinical pregnancy rate
Time frame: 2 years
AMH level during stimulation
Time frame: 2 years
Inhibin B level during stimulation
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: No
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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.
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 recFSH in people with Infertility, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 9 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: status not confirmed, as of the sponsor's last update on 12 Apr 2023. 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 Belgium. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christine Wyns, MD, PhD (003227649501, christine.wyns@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of mature follicles (time frame: 2 years). The study lists 3 primary outcomes in all. 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 12 Apr 2023.