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Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Technology

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ClinicalTrials.gov Identifier: NCT02942849
Recruitment Status : Completed
First Posted : October 24, 2016
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Finox AG

Brief 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

Condition or disease Intervention/treatment
Infertility Drug: r-hFSH

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.

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Study Type : Observational
Actual Enrollment : 1195 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Technology
Actual Study Start Date : September 2016
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Intervention Details:
  • Drug: r-hFSH
    As per standard clinical practice
    Other Name: Bemfola


Primary Outcome Measures :
  1. Number of oocytes retrieved [ Time Frame: 34-36 hours after hCG administration ]

Secondary Outcome Measures :
  1. Antral Follicle Count (AFC) [ Time Frame: Day 1 ]
  2. Basal FSH level [ Time Frame: Day 1 ]
  3. r-hFSH dose on first and last day of stimulation [ Time Frame: Day 1 of stimulation through to maximum Day 16 of stimulation ]
  4. Days of FSH stimulation (with r-hFSH daily doses) [ Time Frame: Day 1 of stimulation through to maximum Day 16 of stimulation ]
  5. r-hFSH total dose [ Time Frame: Day 1 of stimulation through to maximum Day 16 of stimulation ]
  6. Type of oocyte trigger (ß-hCG / GnRH agonist) [ Time Frame: At Day of hCG administration ]
  7. Number of oocytes fertilized (classified as 2PN stages) [ Time Frame: Day 1,2,3 or 5 after ovum pick-up/fertilisation ]
  8. Number of 2PN cells cryopreserved [ Time Frame: Day 1,2,3 or 5 after ovum pick-up/fertilisation ]
  9. Number of embryos transferred [ Time Frame: Day 2-5 after ovum pick-up ]
  10. Proportion of Biochemical pregnancies (determined by serum B-hCG levels) [ Time Frame: 15-20 days after oocyte retrieval ]
  11. Implantation rate (gestational sacs with heartbeat per total number of embryos transferred) [ Time Frame: 15-20 days after oocyte retrieval ]
  12. Incidence of Ovarian Hyper-Stimulation Syndrome (OHSS), classified as mild, moderate and severe [ Time Frame: From Day 1 of stimulation ]
  13. Incidence of ALL other Treatment-Emergent Adverse Events [ Time Frame: From Day 1 of study period ]
  14. Proportion of clinical pregnancies (determined by the presence of a gestational sac) [ Time Frame: 35-42 days after oocyte retrieval ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02942849


Locations
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Germany
Team Kinderwunsch Oldenburg
Oldenburg, Lower Saxony, Germany, 26121
Sponsors and Collaborators
Finox AG
Investigators
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Principal Investigator: Jan-Steffen Krüssel, MD Leiter universitäres interdisziplinäres Kinderwunschzentrum Düsseldorf (UniKiD)
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Responsible Party: Finox AG
ClinicalTrials.gov Identifier: NCT02942849    
Other Study ID Numbers: FIN-BEM-2016-04
First Posted: October 24, 2016    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Finox AG:
Bemfola
r-hFSH
Oocytes
Pregnancy
OHSS
Additional relevant MeSH terms:
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Infertility