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

February 4, 2020 updated by: Finox AG

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1222

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08017
        • IVI Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total number of oocytes retrieved
Time Frame: 34-36 hours after hCG administration and after a maximum 16 days of r-hFSH treatment
34-36 hours after hCG administration and after a maximum 16 days of r-hFSH treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (ACTUAL)

April 1, 2018

Study Completion (ACTUAL)

April 1, 2019

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

October 20, 2016

First Posted (ESTIMATE)

October 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIN-BEM-2015-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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