Trials / Completed
CompletedNCT04503707
Study to Assess the Design of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures in Routine Clinical Practice
French Prospective Multicentre Non-Interventional Study to Assess the Design of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures in Routine Clinical Practice
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 250 (actual)
- Sponsor
- Ferring Pharmaceuticals · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- —
Summary
The aim of the study is to explore how the individualized dosing regimen of REKOVELLE is used in routine clinical practice and to describe the effectiveness and safety of REKOVELLE under real-world conditions.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Follitropin Delta | The Intervention (solution for injection) is delivered with a pre-filled injection pen. The REKOVELLE dose will be based on a recent determination (within the last 12 months) of AMH (anti- müllerian hormone) measured by the ELECSYS AMH Plus Immunoassay. |
Timeline
- Start date
- 2020-06-17
- Primary completion
- 2021-10-31
- Completion
- 2021-10-31
- First posted
- 2020-08-07
- Last updated
- 2021-12-14
Locations
14 sites across 1 country: France
Source: ClinicalTrials.gov record NCT04503707. Inclusion in this directory is not an endorsement.