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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1222 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2019-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02942849

Infertility

COMPLETED

Initiation of Ovarian Stimulation With Recombinant-human FSH (Bemfola®) in the Late Follicular Phase

NCT03767218

Infertility, Female

COMPLETED PHASE3

Luteal Phase-start Ovarian Stimulation With Corifollitropin Alfa

NCT03555942

Infertility

COMPLETED NA

A Prospective, Multi-centric Observational Study to Determine the Mono-bifollicular Development in Infertile Women Subjected to Ovulation Induction With Follitropin α

NCT01111084

Ovulation Induction

COMPLETED

Evolutive Potential of Embryos Obtained From Oocytes After Luteal Phase Ovarian Stimulation

NCT01645241

INFERTILITY Fertility Preservation Ovulation Induction +2 more

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infertility

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

r-hFSH

As per standard practice

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Bemfola

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No