Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Techniques in Spain.
BIRTH
Ambispective Observational Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Techniques in Spain.
1 other identifier
observational
1,222
1 country
1
Brief Summary
Non-comparative, observational, ambispective post-authorisation study (EPA-SP).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 18, 2016
CompletedFirst Posted
Study publicly available on registry
October 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2019
CompletedFebruary 5, 2020
February 1, 2020
1.5 years
October 18, 2016
February 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total number of oocytes retrieved
34-36 hours after hCG administration and after a maximum 16 days of r-hFSH treatment
Secondary Outcomes (5)
Number of fertilised oocytes
1 day after ovum pick-up
Quality of oocytes
At Day 4-5
Number and quality of transferred embryos
Day of embryo transfer, either 2,3 or 5 days after oocyte retrieval
Fertilization and implantation rate
5 to 6 weeks after oocyte retrieval
Incidence of serious adverse events, including moderate-to-severe OHSS
From Day 1 of stimulation
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients listed
- Presence of tumours of the hypothalamus or pituitary gland
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Finox AGlead
Study Sites (1)
IVI Barcelona
Barcelona, 08017, Spain
Related Publications (1)
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.
PMID: 32742711DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2016
First Posted
October 21, 2016
Study Start
October 1, 2016
Primary Completion
April 1, 2018
Study Completion
April 1, 2019
Last Updated
February 5, 2020
Record last verified: 2020-02