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Completed

NCT Number: NCT02941341

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).

Completed

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

IVI Barcelona

Barcelona, 08017, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

r-hFSH

Drug

As per standard practice

Other names: Bemfola

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Finox AG

Industry

Registry information

Official study title

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

Acronym: BIRTH

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Oct 21, 2016
Registry last updated
Feb 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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