Infertility, Female
Conditions
Keywords
Follitropin Delta, REKOVELLE
Brief summary
This post-marketing surveillance study was conducted in accordance with the regulations for re-examination of domestic new drugs (Standard for Re-Examination of New Drugs: Ministry of Food and Drug Safety \[MFDS\]: Notification No. 2017-95, 21 Nov, 2017). It was important to monitor the pattern of drug use in general practice for a long term after marketing authorization, and to investigate and identify potential new adverse events (AEs) and their onset status that were not observed during the drug development phases and any potential factors that affect safety and effectiveness of the new drug.
Interventions
OTHEROther: Non intervention
Non intervention
Sponsors
Ferring Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participants who were prescribed with REKOVELLE (follitropin delta) for the first time according to the approved administration method and dose * Participants who have consented to personal information use
Exclusion criteria
* Participants who are prohibited from use according to the special warnings and precautions for use of REKOVELLE (follitropin delta)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Technical malfunction of REKOVELLE pre-filled pen | Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination |
| Proportion of subjects with non-serious ADRs | Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination |
| Proportion of subjects with ovarian hyperstimulation syndrome (OHSS) | Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination |
| Proportion of subjects with serious AEs and adverse drug reactions (ADRs) | Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination |
| Proportion of subjects with unexpected AEs/ADRs not reflected in 'Precautions for Use' | Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination |
| Proportion of subjects with expected ADRs | Until the 10 to 11 weeks after the embryo transfer or until the 30 days after treatment termination |
Secondary
| Measure | Time frame |
|---|---|
| Ongoing pregnancy rate in women undergoing controlled ovarian stimulation | Between 10-11 weeks after embryo transfer |
| Number of the oocytes retrieved | At the oocyte retrieval visit, after completion of controlled ovarian stimulation and approximately 36 hours after human chorionic gonadotropin (hCG) administration. |
Countries
South Korea
Outcome results
None listed