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Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Techniques in Spain. (BIRTH)

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ClinicalTrials.gov Identifier: NCT02941341
Recruitment Status : Completed
First Posted : October 21, 2016
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Finox AG

Brief Summary:
Non-comparative, observational, ambispective post-authorisation study (EPA-SP).

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

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Study Type : Observational
Actual Enrollment : 1222 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ambispective Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Techniques in Spain.
Study Start Date : October 2016
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2019

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


Primary Outcome Measures :
  1. Total number of oocytes retrieved [ Time Frame: 34-36 hours after hCG administration and after a maximum 16 days of r-hFSH treatment ]

Secondary Outcome Measures :
  1. Number of fertilised oocytes [ Time Frame: 1 day after ovum pick-up ]
  2. Quality of oocytes [ Time Frame: At Day 4-5 ]
  3. Number and quality of transferred embryos [ Time Frame: Day of embryo transfer, either 2,3 or 5 days after oocyte retrieval ]
  4. Fertilization and implantation rate [ Time Frame: 5 to 6 weeks after oocyte retrieval ]
  5. Incidence of serious adverse events, including moderate-to-severe OHSS [ Time Frame: From Day 1 of stimulation ]


Information from the National Library of Medicine

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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
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients listed
  • Presence of tumours of the hypothalamus or pituitary gland

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): NCT02941341


Locations
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Spain
IVI Barcelona
Barcelona, Spain, 08017
Sponsors and Collaborators
Finox AG
Investigators
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Principal Investigator: Marcos Ferrando, MD Director IVI Bilbao, Spain
Principal Investigator: Buenaventura Coroleu Lletget, MD Jefe del Servicio de Medicina de la Reproducción,Hospital Universitari Quirón Dexeus, Barcelona, Spain
Principal Investigator: Luis Rodríguez-Tabernero Martín, MD Jefe de la Unidad de Reproducción, Hospital Clínico Universitario de Valladolid, Valladolid, Spai^n
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Finox AG
ClinicalTrials.gov Identifier: NCT02941341    
Other Study ID Numbers: FIN-BEM-2015-01
First Posted: October 21, 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
ART
Oocytes
OHSS
Pregnancy
Additional relevant MeSH terms:
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Infertility