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

NCT ID: NCT06561958

Last Updated: 2025-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-27

Study Completion Date

2027-08-01

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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REKOVELLE

Participants prescribed REKOVELLE for the first time for controlled ovarian stimulation.

REKOVELLE

Intervention Type DRUG

Individualised dosing regiment of REKOVELLE in routine clinical practice.

Interventions

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REKOVELLE

Individualised dosing regiment of REKOVELLE in routine clinical practice.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ferring Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Global Clinical Compliance

Role: STUDY_DIRECTOR

Ferring Pharmaceuticals

Locations

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Ferring Investigational Site

Chiba, Chiba, Japan

Site Status RECRUITING

Ferring Investigational Site

Fukuoka, Fukuoka, Japan

Site Status RECRUITING

Ferring Investigational Site

Kitakyushu, Fukuoka, Japan

Site Status RECRUITING

Ferring Investigational Site

Takasaki, Gunma, Japan

Site Status RECRUITING

Ferring Investigational Site

Hiroshima, Hiroshima, Japan

Site Status RECRUITING

Ferring Investigational Site

Bunkyō City, Japan, Japan

Site Status RECRUITING

Ferring Investigational Site

Tokyo, Tokyo, Japan

Site Status RECRUITING

Ferring Investigational Site

Hiroshima, , Japan

Site Status RECRUITING

Ferring Investigational Site

Hokkaido, , Japan

Site Status RECRUITING

Ferring Investigational Site

Hyōgo, , Japan

Site Status RECRUITING

Ferring Investigational Site

Osaka, , Japan

Site Status RECRUITING

Ferring Investigational Site

Osaka, , Japan

Site Status RECRUITING

Ferring Investigational Site

Saitama, , Japan

Site Status RECRUITING

Ferring Investigational Site

Busan, Busan, South Korea

Site Status RECRUITING

Ferring Investigational Site

Daegu, Daegu, South Korea

Site Status RECRUITING

Ferring Investigational Site

Seongnam-si, Seongnam, South Korea

Site Status RECRUITING

Ferring Investigational Site

Busan, , South Korea

Site Status RECRUITING

Maria Fertility Hospital

Seoul, , South Korea

Site Status RECRUITING

Ferring Investigational Site

Tainan City, Tainan, Taiwan

Site Status RECRUITING

Ferring Investigational Site

Tainan City, Tainan, Taiwan

Site Status RECRUITING

Ferring Investigational Site

Taoyuan District, Taoyuan, Taiwan

Site Status RECRUITING

Ferring Investigational Site

Taichung, , Taiwan

Site Status RECRUITING

Ferring Investigational Site

Taipei, , Taiwan

Site Status RECRUITING

Ferring Investigational Site

Taipei, , Taiwan

Site Status RECRUITING

Naresuan University Hospital

Phitsanulok, Muang, Thailand

Site Status RECRUITING

Ramathibodi Hospital

Bangkok, Ratchathewi, Thailand

Site Status RECRUITING

Ferring Investigational Site

Bangkok, , Thailand

Site Status RECRUITING

Ferring Investigational Site

Hanoi, Hanoi, Vietnam

Site Status RECRUITING

Ferring Investigational Site

Ho Chi Minh City, Ho Chi Minh City, Vietnam

Site Status RECRUITING

Ferring Investigational Site

Ho Chi Minh City, Ho Chi Minh City, Vietnam

Site Status RECRUITING

Ferring Investigational Site

Huế, Huế, Vietnam

Site Status RECRUITING

Countries

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Japan South Korea Taiwan Thailand Vietnam

Central Contacts

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Global Clinical Compliance

Role: CONTACT

862-286-5200

Facility Contacts

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Global Clinical Compliance

Role: primary

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Other Identifiers

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000430

Identifier Type: -

Identifier Source: org_study_id

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