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NCT Number: NCT02942849

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

Prospective, non-comparative, multi-centre, multi-country, observational post-authorization study, to correlate predictive factors with number of oocytes in relation to the gonadotropin dose administered using a new r-hFSH product (Bemfola®) for ovarian stimulation and GnRH-antagonists for pituitary suppression

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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

Team Kinderwunsch Oldenburg

Oldenburg, Lower Saxony, 26121, Germany

About this study

This will be a prospective, non-comparative, multi-centre, multi-country, observational post-authorization study in Germany and Austria. The study will evaluate the use of follitropin alfa (Bemfola®) in controlled ovarian stimulation for IVF/ICSI.

About 30 ART centres will be involved in the study. Upon site initiation, each investigator site will enrol the subjects who meet the inclusion criteria.

As this is an observational study, there will be no additional treatment or diagnostic procedures performed on subjects other than those of the investigators' local routine clinical practice. The decision to start ART treatment and to use Bemfola® in controlled ovarian hyperstimulation (COH) following a GnRH antagonist protocol will be made independently by the investigators as per the ART centre's protocol, preceding patient enrollment for this study.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female subject justifying an IVF/ICSI treatment
  • Age over 18 years (inclusive) at the time of the screening visit
  • Signed informed patient consent
  • Received only Bemfola® for ovarian stimulation
  • Pituitary suppression with GnRH-antagonists

Exclusion criteria

  • Hypersensitivity to the active substance follitropin alfa, FSH or to any of the excipients
  • Tumours of the hypothalamus or pituitary gland
  • Ovarian enlargement or ovarian cyst not due to polycystic ovarian syndrome
  • Gynaecological haemorrhages of unknown aetiology
  • Ovarian, uterine or mammary carcinoma

Treatment and study plan

r-hFSH

Drug

As per standard clinical practice

Other names: Bemfola

Primary outcomes

  1. Number of oocytes retrieved

    Time frame: 34-36 hours after hCG administration

Secondary outcomes

  1. Antral Follicle Count (AFC)

    Time frame: Day 1

  2. Basal FSH level

    Time frame: Day 1

  3. r-hFSH dose on first and last day of stimulation

    Time frame: Day 1 of stimulation through to maximum Day 16 of stimulation

  4. Days of FSH stimulation (with r-hFSH daily doses)

    Time frame: Day 1 of stimulation through to maximum Day 16 of stimulation

  5. r-hFSH total dose

    Time frame: Day 1 of stimulation through to maximum Day 16 of stimulation

  6. Type of oocyte trigger (ß-hCG / GnRH agonist)

    Time frame: At Day of hCG administration

  7. Number of oocytes fertilized (classified as 2PN stages)

    Time frame: Day 1,2,3 or 5 after ovum pick-up/fertilisation

  8. Number of 2PN cells cryopreserved

    Time frame: Day 1,2,3 or 5 after ovum pick-up/fertilisation

  9. Number of embryos transferred

    Time frame: Day 2-5 after ovum pick-up

  10. Proportion of Biochemical pregnancies (determined by serum B-hCG levels)

    Time frame: 15-20 days after oocyte retrieval

  11. Implantation rate (gestational sacs with heartbeat per total number of embryos transferred)

    Time frame: 15-20 days after oocyte retrieval

  12. Incidence of Ovarian Hyper-Stimulation Syndrome (OHSS), classified as mild, moderate and severe

    Time frame: From Day 1 of stimulation

  13. Incidence of ALL other Treatment-Emergent Adverse Events

    Time frame: From Day 1 of study period

  14. Proportion of clinical pregnancies (determined by the presence of a gestational sac)

    Time frame: 35-42 days after oocyte retrieval

Sponsors and collaborators

Lead sponsor

Finox AG

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Oct 24, 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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