InfertilityNCT02942849
Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Technology
An observational study of Infertility, run by Finox AG at 1 site in Germany.
Trial summary
Prospective, non-comparative, multi-centre, multi-country, observational post-authorization study, to correlate predictive factors with number of oocytes in relation to the gonadotropin dose administered using a new r-hFSH product (Bemfola®) for ovarian stimulation and GnRH-antagonists for pituitary suppression 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
- 1,195 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2016to Dec 2018
- 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: The study population will comprise 1800 women intending to undergo ovarian stimulation with Bemfola® in order to have follicular puncture and oocyte retrieval performed as part of an in vitro fertilisation cycle with or without intracytoplasmic sperm injection, for reproductive purposes, and who are pituitary-suppressed with a GnRH antagonist. About 30 Fertility centres will be involved in the study. Upon site initiation, each investigator site will enrol the subjects who meet the inclusion criteria.
Who may be able to join
- Female subject justifying an IVF/ICSI treatment
- Age over 18 years (inclusive) at the time of the screening visit
- Signed informed patient consent
- Received only Bemfola® for ovarian stimulation
- Pituitary suppression with GnRH-antagonists
Who cannot join
- Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients
- Tumours of the hypothalamus or pituitary gland
- Ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome
- Gynaecological haemorrhages of unknown aetiology
- Ovarian, uterine or mammary carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Technology
Prospective, non-comparative, multi-centre, multi-country, observational post-authorization study, to correlate predictive factors with number of oocytes in relation to the gonadotropin dose administered using a new r-hFSH product (Bemfola®) for ovarian stimulation and GnRH-antagonists for pituitary suppression
Read the detailed description
This will be a prospective, non-comparative, multi-centre, multi-country, observational post-authorization study in Germany and Austria. The study will evaluate the use of follitropin alfa (Bemfola®) in controlled ovarian stimulation for IVF/ICSI.
About 30 ART centres will be involved in the study. Upon site initiation, each investigator site will enrol the subjects who meet the inclusion criteria.
As this is an observational study, there will be no additional treatment or diagnostic procedures performed on subjects other than those of the investigators' local routine clinical practice. The decision to start ART treatment and to use Bemfola® in controlled ovarian hyperstimulation (COH) following a GnRH antagonist protocol will be made independently by the investigators as per the ART centre's protocol, preceding patient enrollment for this study.
- Conditions
- Infertility
- Being tested
- r-hFSH
- Keywords
- Bemfola, r-hFSH, Oocytes, Pregnancy, OHSS
- 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 clinical practice
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of oocytes retrieved
Measured: 34-36 hours after hCG administration
Secondary outcomes (14)
Antral Follicle Count (AFC)
Measured: Day 1
Basal FSH level
Measured: Day 1
r-hFSH dose on first and last day of stimulation
Measured: Day 1 of stimulation through to maximum Day 16 of stimulation
Days of FSH stimulation (with r-hFSH daily doses)
Measured: Day 1 of stimulation through to maximum Day 16 of stimulation
r-hFSH total dose
Measured: Day 1 of stimulation through to maximum Day 16 of stimulation
Type of oocyte trigger (ß-hCG / GnRH agonist)
Measured: At Day of hCG administration
Number of oocytes fertilized (classified as 2PN stages)
Measured: Day 1,2,3 or 5 after ovum pick-up/fertilisation
Number of 2PN cells cryopreserved
Measured: Day 1,2,3 or 5 after ovum pick-up/fertilisation
Number of embryos transferred
Measured: Day 2-5 after ovum pick-up
Proportion of Biochemical pregnancies (determined by serum B-hCG levels)
Measured: 15-20 days after oocyte retrieval
Implantation rate (gestational sacs with heartbeat per total number of embryos transferred)
Measured: 15-20 days after oocyte retrieval
Incidence of Ovarian Hyper-Stimulation Syndrome (OHSS), classified as mild, moderate and severe
Measured: From Day 1 of stimulation
Incidence of ALL other Treatment-Emergent Adverse Events
Measured: From Day 1 of study period
Proportion of clinical pregnancies (determined by the presence of a gestational sac)
Measured: 35-42 days after oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study startSep 2016
- Primary completionDec 2018
- Study completionDec 2018
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Finox AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan-Steffen Krüssel, MD, Principal investigator, Leiter universitäres interdisziplinäres Kinderwunschzentrum Düsseldorf (UniKiD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02942849
- Sponsor's protocol ID
- FIN-BEM-2016-04
- Status last verified
- Feb 2020
- First submitted
- 20 Oct 2016
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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
- Prospective Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Technology
- ClinicalTrials.gov ID
- NCT02942849
- Acronym / sponsor ID
- FIN-BEM-2016-04
- Conditions
- Infertility
- Keywords
- Bemfola, r-hFSH, Oocytes, Pregnancy, OHSS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,195 participants (actual)
- Lead sponsor
- Finox AGIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 24 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.
Prospective, non-comparative, multi-centre, multi-country, observational post-authorization study, to correlate predictive factors with number of oocytes in relation to the gonadotropin dose administered using a new r-hFSH product (Bemfola®) for ovarian stimulation and GnRH-antagonists for pituitary suppression
Detailed description
This will be a prospective, non-comparative, multi-centre, multi-country, observational post-authorization study in Germany and Austria. The study will evaluate the use of follitropin alfa (Bemfola®) in controlled ovarian stimulation for IVF/ICSI.
About 30 ART centres will be involved in the study. Upon site initiation, each investigator site will enrol the subjects who meet the inclusion criteria.
As this is an observational study, there will be no additional treatment or diagnostic procedures performed on subjects other than those of the investigators' local routine clinical practice. The decision to start ART treatment and to use Bemfola® in controlled ovarian hyperstimulation (COH) following a GnRH antagonist protocol will be made independently by the investigators as per the ART centre's protocol, preceding patient enrollment for this study.
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
- The study population will comprise 1800 women intending to undergo ovarian stimulation with Bemfola® in order to have follicular puncture and oocyte retrieval performed as part of an in vitro fertilisation cycle with or without intracytoplasmic sperm injection, for reproductive purposes, and who are pituitary-suppressed with a GnRH antagonist. About 30 Fertility centres will be involved in the study. Upon site initiation, each investigator site will enrol the subjects who meet the inclusion criteria.
Key inclusion criteria (5 listed)
- Female subject justifying an IVF/ICSI treatment
- Age over 18 years (inclusive) at the time of the screening visit
- Signed informed patient consent
- Received only Bemfola® for ovarian stimulation
- Pituitary suppression with GnRH-antagonists
Key exclusion criteria (5 listed)
- Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients
- Tumours of the hypothalamus or pituitary gland
- Ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome
- Gynaecological haemorrhages of unknown aetiology
- Ovarian, uterine or mammary carcinoma
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 clinical practice | Drug | – |
Primary outcome
Number of oocytes retrieved
Time frame: 34-36 hours after hCG administration
14 secondary outcomes
Antral Follicle Count (AFC)
Time frame: Day 1
Basal FSH level
Time frame: Day 1
r-hFSH dose on first and last day of stimulation
Time frame: Day 1 of stimulation through to maximum Day 16 of stimulation
Days of FSH stimulation (with r-hFSH daily doses)
Time frame: Day 1 of stimulation through to maximum Day 16 of stimulation
r-hFSH total dose
Time frame: Day 1 of stimulation through to maximum Day 16 of stimulation
Type of oocyte trigger (ß-hCG / GnRH agonist)
Time frame: At Day of hCG administration
Number of oocytes fertilized (classified as 2PN stages)
Time frame: Day 1,2,3 or 5 after ovum pick-up/fertilisation
Number of 2PN cells cryopreserved
Time frame: Day 1,2,3 or 5 after ovum pick-up/fertilisation
Number of embryos transferred
Time frame: Day 2-5 after ovum pick-up
Proportion of Biochemical pregnancies (determined by serum B-hCG levels)
Time frame: 15-20 days after oocyte retrieval
Implantation rate (gestational sacs with heartbeat per total number of embryos transferred)
Time frame: 15-20 days after oocyte retrieval
Incidence of Ovarian Hyper-Stimulation Syndrome (OHSS), classified as mild, moderate and severe
Time frame: From Day 1 of stimulation
Incidence of ALL other Treatment-Emergent Adverse Events
Time frame: From Day 1 of study period
Proportion of clinical pregnancies (determined by the presence of a gestational sac)
Time frame: 35-42 days after oocyte retrieval
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.
- 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.
Jan-Steffen Krüssel, MD principal investigator
Leiter universitäres interdisziplinäres Kinderwunschzentrum Düsseldorf (UniKiD)
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 Germany.
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 5 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 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 Germany. 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?
Number of oocytes retrieved (time frame: 34-36 hours after hCG administration). 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 5 Feb 2020.