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Can a fertility drug's safety be tracked in real-world use?

NCT ID NCT06545877

Knowledge-focused Sponsor: Ferring Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time

Summary

This survey follows people who use the REKOVELLE pen, which contains the hormone follitropin delta, to stimulate the ovaries during assisted reproduction like IVF or ICSI. The goal is to track how often side effects occur when the drug is used in everyday clinical practice. Researchers will collect data from about 571 participants who have already received the drug and agreed to take part. The findings will help clarify the safety profile of this treatment in a real-world setting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
follitropin delta (REKOVELLE pen)
What this could lead to
If the survey shows a favorable safety profile, it could support the continued use of REKOVELLE for ovarian stimulation in fertility treatments.
What could go wrong
This is an observational survey, not a controlled trial, so it cannot prove cause and effect. It may not capture all rare side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

571 people

The number who actually took part.

Started

Sep 2022

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

infertility disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Infertility

Contacts and locations

Locations

  • Ferring Investigational Site

    Omitama, Ibaraki, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.