Infertility, FemalePhase 3NCT03767218
Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular Phase
A Phase 3 study testing Late follicular phase stimulation with recombinant-human FSH and Early follicular phase stimulation with recombinant-human FSH in people with Infertility, Female, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
A randomised controlled open-label clinical trial to compare the outcome parameters after ovarian stimulation using recombinant-human FSH (follicle stimulating hormone), starting on day 2 of the cycle versus start in the late follicular phase of the cycle. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Late follicular phase stimulation with recombinant-human FSH and Early follicular phase stimulation with recombinant-human FSH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Nov 2018to 25 Nov 2022
- Phase
- Phase 3
- 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 36 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- oocyte donor patients
- Age from 18 to 36 years
- BMI 19 to 35
- Regular menstrual cycle length i.e. 24-35 days
Who cannot join
- Patients with AMH <1.1 ng/ml and/or AFC<7
- Patients with FNPO (Follicle Number Per Ovary) ≥ 19 and/ord AMH >5ng/ml
- Endometriosis grade 3-4
- Oligo-amenorrhea
- Any untreated endocrine abnormality
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular Phase, a Randomised Controlled Pilot Study.
A randomised controlled open-label clinical trial to compare the outcome parameters after ovarian stimulation using recombinant-human FSH (follicle stimulating hormone), starting on day 2 of the cycle versus start in the late follicular phase of the cycle.
Read the detailed description
Objective: To determine whether late follicular stimulation using recombinant-human FSH has comparable outcomes to treatment using recombinant-human FSH in early follicular phase in a flexible GnRH (Gonadotropin-releasing hormone) antagonist protocol, in oocyte donor patients.
Design: Open label, phase 3 randomized trial using a two-arm design with 1:1 allocation ratio
Patients: Oocyte donors (aged 18-36 years)
Intervention(s): Reference group: Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger.
Investigational group: Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle (evaluation trough ultrasound and hormonal assessment) onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH (Luteinizing Hormone) > 10 IU/L, till day of trigger.
Oocyte maturation trigger with GnRH agonist (0.2mg Gonapeptyl) in both groups.
- Conditions
- Infertility, Female
- Being tested
- Late follicular phase stimulation with recombinant-human FSH, Early follicular phase stimulation with recombinant-human FSH
- Keywords
- Oocyte donor, Ovarian stimulation
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Late follicular phase stimulation with recombinant-human FSHCombination product
Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH > 10 IU/L, till day of trigger.
Early follicular phase stimulation with recombinant-human FSHCombination product
Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger.
| Study group | Role | What they receive |
|---|---|---|
| Late follicular phase stimulation with recombinant-human FSH | Experimental | Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH > 10 IU/L, till day of trigger. Receives: Combination Product: Late follicular phase stimulation with recombinant-human FSH |
| Early follicular phase stimulation with recombinant-human FSH | Active comparator | Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger. Receives: Combination Product: Early follicular phase stimulation with recombinant-human FSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
total amount of COC (cumulus-oocyte-complex)
Measured: at oocyte aspiration
Secondary outcomes (9)
Endocrine profile
LH (Luteinising hormone) level
Measured: on menstrual cycle day 2 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group
Endocrine profile
FSH level
Measured: on menstrual cycle day 2 and 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group
Endocrine profile
Progesterone level
Measured: on menstrual cycle day 2 and 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group
Endocrine profile
Estradiol level
Measured: on menstrual cycle day 2 and 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group
Consumption of gonadotrophins
totaal amount of IU (international units) used
Measured: during the ovarian stimulation
Number of days needed for ovarian stimulation
Measured: during the ovarian stimulation
Days of GnRH antagonist use
Measured: during the ovarian stimulation
Total number of mature oocytes
Measured: at day of oocyte aspiration
Total medication cost
Measured: during the ovarian stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Nov 2018
- Primary completion27 May 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open label, phase 3 pilot randomized trial using a two-arm design with 1:1 allocation ratio
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03767218
- Sponsor's protocol ID
- D2.D12.Bemfola
- Status last verified
- Apr 2022
- First submitted
- 17 May 2018
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular Phase, a Randomised Controlled Pilot Study.
- ClinicalTrials.gov ID
- NCT03767218
- Acronym / sponsor ID
- D2.D12.Bemfola
- Conditions
- Infertility, Female
- Keywords
- Oocyte donor, Ovarian stimulation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 27 May 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 6 Dec 2018 (actual)
- 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.
A randomised controlled open-label clinical trial to compare the outcome parameters after ovarian stimulation using recombinant-human FSH (follicle stimulating hormone), starting on day 2 of the cycle versus start in the late follicular phase of the cycle.
Detailed description
Objective: To determine whether late follicular stimulation using recombinant-human FSH has comparable outcomes to treatment using recombinant-human FSH in early follicular phase in a flexible GnRH (Gonadotropin-releasing hormone) antagonist protocol, in oocyte donor patients.
Design: Open label, phase 3 randomized trial using a two-arm design with 1:1 allocation ratio
Patients: Oocyte donors (aged 18-36 years)
Intervention(s): Reference group: Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger.
Investigational group: Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle (evaluation trough ultrasound and hormonal assessment) onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH (Luteinizing Hormone) > 10 IU/L, till day of trigger.
Oocyte maturation trigger with GnRH agonist (0.2mg Gonapeptyl) in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open label, phase 3 pilot randomized trial using a two-arm design with 1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| Late follicular phase stimulation with recombinant-human FSH | Experimental | Combination Product: Late follicular phase stimulation with recombinant-human FSHStart of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH > 10 IU/L, till day of trigger. |
| Early follicular phase stimulation with recombinant-human FSH | Active comparator | Combination Product: Early follicular phase stimulation with recombinant-human FSHStart of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- oocyte donor patients
- Age from 18 to 36 years
- BMI 19 to 35
- Regular menstrual cycle length i.e. 24-35 days
Key exclusion criteria (5 listed)
- Patients with AMH <1.1 ng/ml and/or AFC<7
- Patients with FNPO (Follicle Number Per Ovary) ≥ 19 and/ord AMH >5ng/ml
- Endometriosis grade 3-4
- Oligo-amenorrhea
- Any untreated endocrine abnormality
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 |
|---|---|---|
| Late follicular phase stimulation with recombinant-human FSHStart of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from the late follicular phase of the menstrual cycle onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH > 10 IU/L, till day of trigger. | Combination product | Late follicular phase stimulation with recombinant-human FSH |
| Early follicular phase stimulation with recombinant-human FSHStart of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger. | Combination product | Early follicular phase stimulation with recombinant-human FSH |
Primary outcome
total amount of COC (cumulus-oocyte-complex)
Time frame: at oocyte aspiration
9 secondary outcomes
Endocrine profile
Time frame: on menstrual cycle day 2 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group
Endocrine profile
Time frame: on menstrual cycle day 2 and 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group
Endocrine profile
Time frame: on menstrual cycle day 2 and 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group
Endocrine profile
Time frame: on menstrual cycle day 2 and 9, (extra days as per site protocol) and day of oocyte maturation trigger in reference group. On menstrual cycle day 2 and 12, (extra days as per site protocol) and day of oocyte maturation trigger in investigational group
Consumption of gonadotrophins
Time frame: during the ovarian stimulation
Number of days needed for ovarian stimulation
Time frame: during the ovarian stimulation
Days of GnRH antagonist use
Time frame: during the ovarian stimulation
Total number of mature oocytes
Time frame: at day of oocyte aspiration
Total medication cost
Time frame: during the ovarian stimulation
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 16 May 2023.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Late follicular phase stimulation with recombinant-human FSH and Early follicular phase stimulation with recombinant-human FSH in people with Infertility, Female, run by Universitair Ziekenhuis Brussel 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 4 inclusion and 5 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 16 May 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
total amount of COC (cumulus-oocyte-complex) (time frame: at oocyte aspiration). 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 16 May 2023.