InfertilityPhase 4BEMDONNCT02503605
Biosimilar Versus Urinary Gonadotropins
A Phase 4 study testing Biosimilar recombinant FSH and Urinary FSH in people with Infertility, run by IVI Madrid at 1 site in Spain.
Trial summary
Biosimilar drug marketing of recombinant FSH for the treatment of infertility is another step in simplifying fertility treatments, making them easier to manage and more accessible to patients. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Biosimilar recombinant FSH and Urinary FSH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2015to Jun 2016
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients aged 18-35 years who meet the criteria for entry into the oocyte donor program and that are going to undergo controlled ovarian stimulation
Who cannot join
- Patient with a basal antral count> 20 follicles in total or <6 antral follicles per ovary
- Patients with comorbidities that, in the opinion of the investigator, may interfere with the treatment of ovarian stimulation
- The presence of ovarian cysts that judgment of the investigator would interfere with the stimulation or may pose a risk to the donor
- BMI <18 kg / m2
- BMI> 30 kg / m2
- Severe hypersensitivity to drugs with similar structure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Randomized Clinical Trial to Test the Efficacy of a Biosimilar Recombinant Follicle Stimulating Hormone (FSH)vs. Urinary FSH in an Oocyte Donation Program
Biosimilar drug marketing of recombinant FSH for the treatment of infertility is another step in simplifying fertility treatments, making them easier to manage and more accessible to patients. Taking in mind these arguments ,the study is proposed for determining equivalence in terms of biological effectiveness of an ovarian stimulation protocol with biosimilar recombinant FSH stimulation protocol vs. urinary FSH in oocyte donation program.
Read the detailed description
Biosimilar products are drugs "like" biotechnological origin to other innovative biological medicines and that can be marketed once the patent has expired. These drugs are intended to achieve the same therapeutic benefit as biological medicinal resembles.
Because of the similarity in both the active substance in the formulation, it is intended to demonstrate the equivalence between the biosimilar medicine of recombinant FSH and FSH of urinary origin in terms of fitness.
The investigators' main objective is to perform a non-inferiority trial of biosimilar recombinant FSH product compared to a conventional ovarian stimulation protocol with urinary FSH in relation to the number of oocytes retrieved and the number of metaphase II oocytes.
- Conditions
- Infertility
- Being tested
- Biosimilar recombinant FSH, Urinary FSH
- Keywords
- Biosimilar, ovarian stimulation, oocyte donor
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biosimilar recombinant FSHDrug
Also called Bemfola
Controlled ovarian stimulation with 150 IU/day biosimilar recombinant FSH
Urinary FSHDrug
Also called Fostipur
Controlled ovarian stimulation with 150 IU/day urinary FSH
| Study group | Role | What they receive |
|---|---|---|
| Biosimilar recombinant FSH | Active comparator | Under current practice, 65 participants will be stimulated with 150 international units (IU)/day biosimilar recombinant FSH, .Daily doses of 0.25 miligrams gonadotropin-releasing hormone (GnRH) antagonist will start on day 6 of stimulation. From this day may also vary the dose of recombinant FSH biosimilar according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.1 miligram GnRH agonist will be administered for triggering final oocyte maturation Receives: Drug: Biosimilar recombinant FSH |
| Urinary FSH | Active comparator | Under current practice, 65 participants will be stimulated with 150 IU/day of urinary FSH. Daily doses of 0.25 miligrams gonadotropin-releasing hormone (GnRH) antagonist will start on day 6 of stimulation From this day may also vary the dose of urinary FSH according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.1 miligram GnRH agonist will be administered for triggering final oocyte maturation Receives: Drug: Urinary FSH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of metaphase II oocytes
Measured: 1 day
Secondary outcomes (10)
Days of treatment
Measured: 2 weeks
Total dose of gonadotropins (IU)
Measured: 2 weeks
Estradiol concentration the day of human chorionic gonadotropin (hCG) administration (picograms/mililiterl)
Measured: 1 day
Progesterone concentration the day of hCG administration (nanograms/mililiter)
Measured: 1 day
Fertilization rate
Measured: 1 day
Percentage of cryopreserved embryos
Measured: 2 weeks
Implantation rate
Measured: 2 weeks
Cancellation rate
Measured: 1 week
Degree of satisfaction (numbers 0-10)
Measured: 1 month
Apoptosis rate in granulosa cells
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startOct 2015
- Primary completionMar 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- IVI Bilbao
- Responsible party
- Principal investigator, Antonio Requena, IVI Madrid
- Investigators
- Antonio Requena, Md, PhD, Principal investigator, IVI Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503605
- Sponsor's protocol ID
- 1504-MAD-024-AR
- Acronym
- BEMDON
- Status last verified
- Jul 2015
- First submitted
- 16 Jul 2015
- Last updated
- 21 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rettenbacher M, Andersen AN, Garcia-Velasco JA, Sator M, Barri P, Lindenberg S, van der Ven K, Khalaf Y, Bentin-Ley U, Obruca A, Tews G, Schenk M, Strowitzki T, Narvekar N, Sator K, Imthurn B. A multi-centre phase 3 study comparing efficacy and safety of Bemfola((R)) versus Gonal-f((R)) in women undergoing ovarian stimulation for IVF. Reprod Biomed Online. 2015 May;30(5):504-13. doi: 10.1016/j.rbmo.2015.01.005. Epub 2015 Jan 27.
PubMed 25735918Wolzt M, Gouya G, Sator M, Hemetsberger T, Irps C, Rettenbacher M, Vcelar B. Comparison of pharmacokinetic and safety profiles between Bemfola((R)) and Gonal-f((R)) after subcutaneous application. Eur J Drug Metab Pharmacokinet. 2016 Jun;41(3):259-65. doi: 10.1007/s13318-015-0257-6. Epub 2015 Jan 30.
PubMed 25633239
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial to Test the Efficacy of a Biosimilar Recombinant Follicle Stimulating Hormone (FSH)vs. Urinary FSH in an Oocyte Donation Program
- ClinicalTrials.gov ID
- NCT02503605
- Acronym / sponsor ID
- BEMDON / 1504-MAD-024-AR
- Conditions
- Infertility
- Keywords
- Biosimilar, ovarian stimulation, oocyte donor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Collaborators
- IVI Bilbao
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 21 Jul 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.
Biosimilar drug marketing of recombinant FSH for the treatment of infertility is another step in simplifying fertility treatments, making them easier to manage and more accessible to patients. Taking in mind these arguments ,the study is proposed for determining equivalence in terms of biological effectiveness of an ovarian stimulation protocol with biosimilar recombinant FSH stimulation protocol vs. urinary FSH in oocyte donation program.
Detailed description
Biosimilar products are drugs "like" biotechnological origin to other innovative biological medicines and that can be marketed once the patent has expired. These drugs are intended to achieve the same therapeutic benefit as biological medicinal resembles.
Because of the similarity in both the active substance in the formulation, it is intended to demonstrate the equivalence between the biosimilar medicine of recombinant FSH and FSH of urinary origin in terms of fitness.
The investigators' main objective is to perform a non-inferiority trial of biosimilar recombinant FSH product compared to a conventional ovarian stimulation protocol with urinary FSH in relation to the number of oocytes retrieved and the number of metaphase II oocytes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biosimilar recombinant FSH | Active comparator | Drug: Biosimilar recombinant FSHUnder current practice, 65 participants will be stimulated with 150 international units (IU)/day biosimilar recombinant FSH, .Daily doses of 0.25 miligrams gonadotropin-releasing hormone (GnRH) antagonist will start on day 6 of stimulation. From this day may also vary the dose of recombinant FSH biosimilar according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.1 miligram GnRH agonist will be administered for triggering final oocyte maturation |
| Urinary FSH | Active comparator | Drug: Urinary FSHUnder current practice, 65 participants will be stimulated with 150 IU/day of urinary FSH. Daily doses of 0.25 miligrams gonadotropin-releasing hormone (GnRH) antagonist will start on day 6 of stimulation From this day may also vary the dose of urinary FSH according ovarian response. In the presence of 3 or more follicles ≥17 mm, a single dose of 0.1 miligram GnRH agonist will be administered for triggering final oocyte maturation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aged 18-35 years who meet the criteria for entry into the oocyte donor program and that are going to undergo controlled ovarian stimulation
Key exclusion criteria (6 listed)
- Patient with a basal antral count> 20 follicles in total or <6 antral follicles per ovary
- Patients with comorbidities that, in the opinion of the investigator, may interfere with the treatment of ovarian stimulation
- The presence of ovarian cysts that judgment of the investigator would interfere with the stimulation or may pose a risk to the donor
- BMI <18 kg / m2
- BMI> 30 kg / m2
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 |
|---|---|---|
| Biosimilar recombinant FSHAlso: BemfolaControlled ovarian stimulation with 150 IU/day biosimilar recombinant FSH | Drug | Biosimilar recombinant FSH |
| Urinary FSHAlso: FostipurControlled ovarian stimulation with 150 IU/day urinary FSH | Drug | Urinary FSH |
Primary outcome
Number of metaphase II oocytes
Time frame: 1 day
10 secondary outcomes
Days of treatment
Time frame: 2 weeks
Total dose of gonadotropins (IU)
Time frame: 2 weeks
Estradiol concentration the day of human chorionic gonadotropin (hCG) administration (picograms/mililiterl)
Time frame: 1 day
Progesterone concentration the day of hCG administration (nanograms/mililiter)
Time frame: 1 day
Fertilization rate
Time frame: 1 day
Percentage of cryopreserved embryos
Time frame: 2 weeks
Implantation rate
Time frame: 2 weeks
Cancellation rate
Time frame: 1 week
Degree of satisfaction (numbers 0-10)
Time frame: 1 month
Apoptosis rate in granulosa cells
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2015.
- Background: PubMed 25735918Rettenbacher M, Andersen AN, Garcia-Velasco JA, Sator M, Barri P, Lindenberg S, van der Ven K, Khalaf Y, Bentin-Ley U, Obruca A, Tews G, Schenk M, Strowitzki T, Narvekar N, Sator K, Imthurn B. A multi-centre phase 3 study comparing efficacy and safety of Bemfola((R)) versus Gonal-f((R)) in women undergoing ovarian stimulation for IVF. Reprod Biomed Online. 2015 May;30(5):504-13. doi: 10.1016/j.rbmo.2015.01.005. Epub 2015 Jan 27.
- Background: PubMed 25633239Wolzt M, Gouya G, Sator M, Hemetsberger T, Irps C, Rettenbacher M, Vcelar B. Comparison of pharmacokinetic and safety profiles between Bemfola((R)) and Gonal-f((R)) after subcutaneous application. Eur J Drug Metab Pharmacokinet. 2016 Jun;41(3):259-65. doi: 10.1007/s13318-015-0257-6. Epub 2015 Jan 30.
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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.
Antonio Requena, Md, PhD principal investigator
IVI Madrid
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 Biosimilar recombinant FSH and Urinary FSH in people with Infertility, run by IVI Madrid at 1 site in Spain.
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 6 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 21 Jul 2015. 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 Spain. 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 Antonio Requena, MD, PhD (+31911802900 ext. 24153, Antonio.Requena@ivi.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of metaphase II oocytes (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02503605, which also lists 2 linked publications.
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 21 Jul 2015.