REKOVELLE PEN for S.C. Injection General Drug Use Survey (Controlled Ovarian Stimulation in Assisted Reproductive Technologies)

Recruiting

• Conditions: Infertility

• Registration Number: NCT06545877
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

This survey targets controlled ovarian stimulation with this drug for the development of multiple oocytes in women undergoing assisted reproduction (ART) such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-16
• Status Verified: 2024-08
• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-06
• Last Update Submitted: 2024-08-06
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-04-30
• Study Completion: 2029-06-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 500

Inclusion Criteria

• Participants who received the REKOVELLE in controlled ovarian stimulation in assisted reproductive technologies and have consented to participate in the survey.

Exclusion Criteria

• No exclusion criteria because data are collected under conditions of use in daily practice.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse Events	From initiation of the administration, in case of embryo transfer is not performed, until 1 week after oocyte collection, and in case embryo transfer is performed, 6 weeks after embryo transfer	Frequency of Adverse Events

Trial Locations

Locations (1)

Ferring Investigational Site; 🇯🇵 Omitama, Ibaraki, Japan