Post-Marketing Surveillance (PMS) Protocol of REKOVELLE Pre-Filled Pen (Follitropin Delta)

Study Overview
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Brief Summary
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This post-marketing surveillance study is 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 is 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.

Official Title
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Post-Marketing Surveillance (PMS) Protocol of REKOVELLE Pre-Filled Pen(Follitropin Delta)

Conditions
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Infertility, Female

Intervention / Treatment
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* Other: Other: Non intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who were prescribed with REKOVELLE (follitropin delta) for the first time according to the approved administration method and dose Patients who have consented to personal information use Exclusion Criteria: Patients who are prohibited from use according to the special warnings and precautions for use of REKOVELLE (follitropin delta)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment of Infertility<br>Non intervention | Other: Other: Non intervention<br>* Non intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| Ongoing pregnancy rate in women undergoing controlled ovarian stimulation |  | Between 10-11 weeks after embryo transfer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Follitropin Delta, REKOVELLE