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Clinical Trials in Japan / NCT06561958
Active, not recruiting Observational

Prospective, Multi-centre, Non-Interventional Study to Investigate the Effectiveness of REKOVELLE® for Ovarian Stimulation for Asian Women in Real World Settings

NCT06561958 · tracked via the Priya Life Science Japan tracker
Sponsor
Ferring Pharmaceuticals
Phase
Observational
Started
2024-08-27
Last updated
2026-09-30

Condition(s) studied

Infertility

Investigational drug(s) / intervention(s)

REKOVELLE →

REKOVELLE: Individualised dosing regiment of REKOVELLE in routine clinical practice.

Study summary

Primary objective is to investigate the effectiveness of REKOVELLE® in women undergoing their first REKOVELLE® ovarian stimulation treatment in real world practice in Asian countries.

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Females aged 20 years or older at enrollment * Serum AMH level \>0.5 ng / mL (with the latest result tested within 12 months) * Who are first time prescribed REKOVELLE for their ovarian stimulation and IVF or ICSI treatment cycle using fresh or frozen ejaculated sperm from male partner or sperm donor (if applicable) * Willing and able to provide written informed consent Exclusion Criteria: * Have undergone more than 2 COS-IVF / ICSI cycles before the enrollment * Participating in an interventional clinical trial in which any medication treatment is mandated * Women with a contraindication for prescription of REKOVELLE treatment * Oocyte donors * Undergoing ovarian stimulation for fertility preservation

Primary outcome measure(s)

  • Cumulative live birth rate — Up to 12 months
    Cumulative live birth rate defined as delivery of at least 1 live fetus after 20 completed weeks of gestation, combined fresh and frozen embryo transfers within 12 months after the start of the ovarian stimulation in patients of the first REKOVELLE ovarian stimulation cycle.

Trial sites (31)

FacilityCityRegionStatus
Ferring Investigational Site Chiba Chiba
Ferring Investigational Site Fukuoka Fukuoka
Ferring Investigational Site Kitakyushu Fukuoka
Ferring Investigational Site Takasaki Gunma
Ferring Investigational Site Hiroshima Hiroshima
Ferring Investigational Site Bunkyō City Japan
Ferring Investigational Site Tokyo Tokyo
Ferring Investigational Site Hiroshima Japan
Ferring Investigational Site Hokkaido Japan
Ferring Investigational Site Hyōgo Japan
Ferring Investigational Site Osaka Japan
Ferring Investigational Site Osaka Japan
Ferring Investigational Site Saitama Japan
Ferring Investigational Site Busan Busan
Ferring Investigational Site Daegu Daegu
Ferring Investigational Site Seongnam-si Seongnam
Ferring Investigational Site Busan South Korea
Maria Fertility Hospital Seoul South Korea
Ferring Investigational Site Tainan Tainan
Ferring Investigational Site Tainan Tainan
Ferring Investigational Site Taoyuan Taoyuan
Ferring Investigational Site Taichung Taiwan
Ferring Investigational Site Taipei Taiwan
Ferring Investigational Site Taipei Taiwan
Naresuan University Hospital Phitsanulok Muang
Ramathibodi Hospital Bangkok Ratchathewi
Ferring Investigational Site Bangkok Thailand
Ferring Investigational Site Hanoi Hanoi
Ferring Investigational Site Ho Chi Minh City Ho Chi Minh City
Ferring Investigational Site Ho Chi Minh City Ho Chi Minh City
Ferring Investigational Site Huế Huế

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06561958 on ClinicalTrials.gov ↗ ← All trials in Japan