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Real-World REKOVELLE study launches for chinese IVF patients

NCT ID NCT07029451

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study will follow 2,500 Chinese women who are prescribed REKOVELLE for the first time during IVF or ICSI treatments. Researchers will track how the drug is used in routine practice, its effectiveness (including live birth rates), and any side effects. The goal is to understand real-world outcomes rather than test a new treatment.

What this could mean

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

Active substance
REKOVELLE (follitropin delta, a follicle-stimulating hormone)
What this could lead to
If successful, this study could provide real-world evidence on how well REKOVELLE works and its safety in Chinese women undergoing IVF, potentially guiding better treatment decisions.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient selection and real-world variability.

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

About 2,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

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 eligible for enrolment in the study are those scheduled for their first REKOVELLE treatment, with no more than one prior COS cycle for IVF or ICSI, and who meet the inclusion and exclusion criteria. Data from approximately 2,500 patients will be collected.

Ages

20 years and older

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: * Women who meet all the following criteria are eligible for participation: * At least 20 years of age (including the 20th birthday) when signing informed consent * Prescribed REKOVELLE for the first time in controlled ovarian stimulation for in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) cycles * Willing and able to provide written informed consent Exclusion Criteria: * Women who meet any of the following criteria are not eligible for participation: * Previously undergone more than 1 controlled ovarian stimulation cycles for IVF or ICSI * Currently participating in an interventional clinical study for which treatment with medication is mandated * Currently undergoing ovarian stimulation for fertility preservation or oocytes donation * Contraindications for the use of REKOVELLE

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • 1st Affiliated Hospital of Nanchang University

    RECRUITING

    Nanchang, Jiangxi, 330006, China

  • 3rd Affiliated Hospital of Guangzhou Medical University (Guangzhou)

    RECRUITING

    Guangzhou, Guangdong, 510000, China

  • 6th Affiliated Hospital of Sun Yat Sen University

    RECRUITING

    Guangzhou, Guandong, 510655, China

  • Affiliated Hospital of Jining Medical University

    RECRUITING

    Jining, Shandong, 272001, China

  • Beijing Chaoyang Hospital (Beijing)

    RECRUITING

    Chaoyang, Beijing Municipality, 100020, China

  • Beijing Obstetrics And Gynecology Hospital Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100006, China

  • Binzhou Medical University Hospital

    RECRUITING

    Binzhou, Shandong, 256600, China

  • General Hospital of Ningxia Medical University

    RECRUITING

    Yinchuan, Ningxia, 750004, China

  • Hubei Maternal and Child Health Hospital

    RECRUITING

    Wuhan, Hubei, 430070, China

  • Jinhua People's Hospital

    RECRUITING

    Jinhua, 321022, China

  • Maanshan Maternal and Child Health Care Hospital

    RECRUITING

    Ma’anshan, Anhui, 243031, China

  • Northwest Women's and Children's Hospital

    RECRUITING

    Xi’an, Shanxi, 710061, China

  • Peking University First Hospital

    RECRUITING

    Xicheng, Beijing Municipality, 100034, China

  • Peking University Third Hospital (Beijing)

    RECRUITING

    Beijing, 100191, China

  • Reproductive & Genetic hospital Of CITIC-Xiangya

    RECRUITING

    Changsha, Hunan, 410008, China

  • Reproductive Hospital Affiliated to Shandong University

    RECRUITING

    Jinan, Shandong, 250001, China

  • Shanghai First Maternal and Child Health Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 201204, China

  • The First Affiliated Hospital of Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230088, China

  • The First Affiliated Hospital of Shantou University Medical College

    RECRUITING

    Shantou, Guangdong, 515041, China

  • The Peoples Hospital of Guangxi Zhuang Autonomous Region

    RECRUITING

    Nanning, 530021, China

  • The Reproduction Hospital of Guangxi Zhuang Autonomous Region

    RECRUITING

    Nanning, 530022, China

  • The Second Affiliated Hospital of Air Force Medical University

    RECRUITING

    Xi'an, Shaanxi, 710038, China

  • The Second Nanning People's Hospital

    RECRUITING

    Nanning, Guangxi, 530000, China

  • Tianjin Medical University General Hospital (Heping District)

    RECRUITING

    Xiaobailou, Tianjin Municipality, 300052, China

  • Tongji Hospital Tongji Medical College of Hust

    RECRUITING

    Wuhan, Hubei, 430034, China

  • Women's hospital School of Medicine Zhejiang University

    RECRUITING

    Hangzhou, Zhejiang, 310006, China

  • Zhejiang Provincial People's Hospital

    RECRUITING

    Hangzhou, 310014, China

  • Zhongshan Hospital Affiliated to Fudan University

    RECRUITING

    Shanghai, 200032, China

More trials for these conditions

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