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

Sponsor

Finox AG (Industry)

Overall Status

Completed

CT.gov ID

NCT02941341

Collaborator

(none)

1,222

Enrollment

Location

Duration (Months)

40.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: r-hFSH

Study Design

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 :

Oct 1, 2016

Actual Primary Completion Date :

Apr 1, 2018

Actual Study Completion Date :

Apr 1, 2019

Outcome Measures

Primary Outcome Measures

Total number of oocytes retrieved [34-36 hours after hCG administration and after a maximum 16 days of r-hFSH treatment]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IVI Barcelona	Barcelona		Spain	08017

Sponsors and Collaborators

Finox AG

Investigators

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