InfertilityBIRTHNCT02941341
Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Techniques in Spain.
An observational study of Infertility, run by Finox AG at 1 site in Spain.
Trial summary
Non-comparative, observational, ambispective post-authorisation study (EPA-SP). 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?
- r-hFSH
- How many people
- 1,222 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2016to Apr 2019
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who have undergone oocyte retrieval after ovarian stimulation with Bemfola®, either as part of an in vitro fertilisation (IVF) cycle or with an intracytoplasmic sperm injection (ICSI), for reproductive purposes or for oocyte donation, and who are pituitary-suppressed with a GnRH antagonist.
Who may be able to join
- Women aged ≥ 18 years
- Currently undergoing an IVF or ICSI cycle or are oocyte-donors
- Have completed controlled ovarian stimulation
- Have received at least 5 doses of Bemfola®
- Are pituitary suppressed with a GnRH antagonist
- Have undergone oocyte retrieval
- Have signed the Informed Consent Form
Who cannot join
- Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients listed
- Presence of tumours of the hypothalamus or pituitary gland
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ambispective Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Techniques in Spain.
Non-comparative, observational, ambispective post-authorisation study (EPA-SP).
- Conditions
- Infertility
- Being tested
- r-hFSH
- Keywords
- Bemfola, r-hFSH, ART, Oocytes, OHSS, Pregnancy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
r-hFSHDrug
Also called Bemfola
As per standard practice
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of oocytes retrieved
Measured: 34-36 hours after hCG administration and after a maximum 16 days of r-hFSH treatment
Secondary outcomes (5)
Number of fertilised oocytes
Measured: 1 day after ovum pick-up
Quality of oocytes
Measured: At Day 4-5
Number and quality of transferred embryos
Measured: Day of embryo transfer, either 2,3 or 5 days after oocyte retrieval
Fertilization and implantation rate
Measured: 5 to 6 weeks after oocyte retrieval
Incidence of serious adverse events, including moderate-to-severe OHSS
Measured: From Day 1 of stimulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionApr 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finox AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marcos Ferrando, MD, Principal investigator, Director IVI Bilbao, SpainBuenaventura Coroleu Lletget, MD, Principal investigator, Jefe del Servicio de Medicina de la Reproducción,Hospital Universitari Quirón Dexeus, Barcelona, SpainLuis Rodríguez-Tabernero Martín, MD, Principal investigator, Jefe de la Unidad de Reproducción, Hospital Clínico Universitario de Valladolid, Valladolid, Spai^n
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02941341
- Sponsor's protocol ID
- FIN-BEM-2015-01
- Acronym
- BIRTH
- Status last verified
- Feb 2020
- First submitted
- 18 Oct 2016
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ferrando M, Coroleu B, Rodriguez-Tabernero L, Barrenetxea G, Guix C, Sanchez F, Jenkins J; BIRTH study group. The continuum of ovarian response leading to BIRTH, a real world study of ART in Spain. Fertil Res Pract. 2020 Jul 29;6:13. doi: 10.1186/s40738-020-00081-4. eCollection 2020.
PubMed 32742711
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambispective Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Techniques in Spain.
- ClinicalTrials.gov ID
- NCT02941341
- Acronym / sponsor ID
- BIRTH / FIN-BEM-2015-01
- Conditions
- Infertility
- Keywords
- Bemfola, r-hFSH, ART, Oocytes, OHSS, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,222 participants (actual)
- Lead sponsor
- Finox AGIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 21 Oct 2016 (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.
Non-comparative, observational, ambispective post-authorisation study (EPA-SP).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who have undergone oocyte retrieval after ovarian stimulation with Bemfola®, either as part of an in vitro fertilisation (IVF) cycle or with an intracytoplasmic sperm injection (ICSI), for reproductive purposes or for oocyte donation, and who are pituitary-suppressed with a GnRH antagonist.
Key inclusion criteria (7 listed)
- Women aged ≥ 18 years
- Currently undergoing an IVF or ICSI cycle or are oocyte-donors
- Have completed controlled ovarian stimulation
- Have received at least 5 doses of Bemfola®
- Are pituitary suppressed with a GnRH antagonist
Key exclusion criteria (2 listed)
- Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients listed
- Presence of tumours of the hypothalamus or pituitary gland
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 |
|---|---|---|
| r-hFSHAlso: BemfolaAs per standard practice | Drug | – |
Primary outcome
Total number of oocytes retrieved
Time frame: 34-36 hours after hCG administration and after a maximum 16 days of r-hFSH treatment
5 secondary outcomes
Number of fertilised oocytes
Time frame: 1 day after ovum pick-up
Quality of oocytes
Time frame: At Day 4-5
Number and quality of transferred embryos
Time frame: Day of embryo transfer, either 2,3 or 5 days after oocyte retrieval
Fertilization and implantation rate
Time frame: 5 to 6 weeks after oocyte retrieval
Incidence of serious adverse events, including moderate-to-severe OHSS
Time frame: From Day 1 of 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 5 Feb 2020.
- Derived from this study: PubMed 32742711Ferrando M, Coroleu B, Rodriguez-Tabernero L, Barrenetxea G, Guix C, Sanchez F, Jenkins J; BIRTH study group. The continuum of ovarian response leading to BIRTH, a real world study of ART in Spain. Fertil Res Pract. 2020 Jul 29;6:13. doi: 10.1186/s40738-020-00081-4. eCollection 2020.
- Individual participant dataSharing planned: Undecided
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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.
Marcos Ferrando, MD principal investigator
Director IVI Bilbao, Spain
Buenaventura Coroleu Lletget, MD principal investigator
Jefe del Servicio de Medicina de la Reproducción,Hospital Universitari Quirón Dexeus, Barcelona, Spain
Luis Rodríguez-Tabernero Martín, MD principal investigator
Jefe de la Unidad de Reproducción, Hospital Clínico Universitario de Valladolid, Valladolid, Spai^n
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Finox AG 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 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 5 Feb 2020. 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.
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 number of oocytes retrieved (time frame: 34-36 hours after hCG administration and after a maximum 16 days of r-hFSH treatment). 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 NCT02941341, which also lists 1 linked publication.
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 5 Feb 2020.