SOFIA
Research type
Research Study
Full title
SOFIA: Safety of Ovaleap® (Follitropin alfa) in Infertile Women Undergoing Superovulation for Assisted Reproductive Technologies. A Multi-National, Comparative, Prospective, Non-Interventional, Observational Cohort Study. Phase 4
IRAS ID
230593
Contact name
David Ogutu
Contact email
Sponsor organisation
Teva Pharmaceuticals Europe BV,
Clinicaltrials.gov Identifier
PRA Project Code, TEAW5005-WH5005
Duration of Study in the UK
2 years, 1 months, 16 days
Research summary
The SOFIA study is a Post Authorisation Safety Study (PASS) requested by the European Medicines Agency (EMA) as a condition of the approval of Ovaleap (Follitropin alfa).
Ovaleap is a biosimilar to Gonal-f, marketed by Merck Serono Europe Ltd. Both of these are recombinant human follicle stimulating hormones (r-hFSH), which stimulate multifollicular development. These treatments are involved in Assisted Reproductive Technology (ART) treatments, such as in vitro fertilization (IVF), gamete intra-fallopian transfer and zygote intra-fallopian transfer. One of the serious adverse outcomes that may occur during (ART) treatment is Ovarian Hyperstimulation Syndrome (OHSS). OHSS is a complication of Ovarian Stimulation with symptoms of ovarian enlargement (in mild cases) to enlarged cystic ovaries (in severe cases). This can be accompanied with symptoms ranging from abdominal discomfort to sever abdominal tension and pain.
The study will examine the risk of OHSS in infertile women undergoing ART treatment with Ovaleap® compared to those treated with Gonal-f®. The study will be conducted at sites specialising in treating women with infertility. Data from study participants will be obtained from approximately 60 centers in countries of the European Union (EU). The study intends to collect data from a similar number of patients using Ovaleap and using Gonal-f in each country. Approximately 410 Ovaleap users and 410 Gonal-f users will be included by participating
Physicians across the EU.Patients will be considered for enrolment in the study after the participating physician has determined the appropriateness of Ovaleap or Gonal-f use.
After study entry, study participants will be observed for one treatment cycle only (of up to 20 days) as part of their routine medical care. They will then be followed until the end of the follow up period, 30 days after the last dose administration of Gonal-f or Ovaleap.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
17/EE/0315
Date of REC Opinion
2 Aug 2017
REC opinion
Further Information Favourable Opinion