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

September 1, 2026 updated by: Ferring Pharmaceuticals

REKOVELLE® PEN S.C. Injection 12μg/36μg/72μg for Controlled Ovarian Stimulation in Assisted Reproductive Technologies - General Drug Use-results Survey

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).

Study Overview

Status

Completed

Conditions

Infertility

Study Type

Observational

Enrollment (Actual)

571

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Japan
- Ibaraki
  - Omitama, Ibaraki, Japan
    - Ferring Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Women who are undergoing assisted reproduction (ART) such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events Time Frame: 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	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ferring Pharmaceuticals

Investigators

Study Director: Global Clinical Compliance, Ferring Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2022

Primary Completion (Actual)

April 30, 2025

Study Completion (Actual)

February 28, 2026

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

August 6, 2024

First Posted (Actual)

August 9, 2024

Study Record Updates

Last Update Posted (Actual)

September 3, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified