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Can a new fertility drug match the standard for IVF egg retrieval?

NCT ID NCT06921395

Disease control Sponsor: LG Chem 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether Fang Le Shu, a recombinant FSH drug, works as well as the standard Gonal-F for ovarian stimulation in women undergoing IVF. About 248 infertile women will receive one of the two drugs to stimulate their ovaries. Researchers will compare the number of eggs retrieved and track pregnancy and live birth rates to see if Fang Le Shu is a viable alternative.

What this could mean

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

Active substance
Fang Le Shu (recombinant FSH), a hormone used to stimulate the ovaries
What this could lead to
If Fang Le Shu works as well as the standard drug, it could offer a new option for ovarian stimulation in IVF, potentially improving egg retrieval and pregnancy rates.
What could go wrong
This is a phase IV trial, so the drug is already approved. The main question is whether it matches the comparator in effectiveness and safety. Individual results may vary, and there are risks like ovarian hyperstimulation syndrome.

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.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 248 people

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

Started

Feb 2025

Expected to finish

Oct 2026

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.

Ages

20 to 39 years

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: * Is pre-menopausal female aged ≥20 to \<40 years. * Has regular menstrual cycles of ≥25 to ≤35 days. * Has Normal baseline serum FSH, LH, E2, P4. * Is able to voluntarily sign the informed consent form (ICF). * Has history of infertility for at least 1 year before the day of randomization; however, subjects with confirmed diagnosis of infertility are eligible without fulfilling the 1-year requirement. Exclusion Criteria: * Has any known clinically significant major systemic disease, or endocrine or metabolic abnormalities with the exception of controlled thyroid function disease. * Has body mass index (BMI) of \>30 kg/m2. * Has clinically significant abnormalities of the uterus, ovary, or appendix prior to the day of randomization * Has history of surgeries that may affect oocyte retrieval or pregnancy outcome, such as surgical resection of uterine mediastinum, fibroids, or cysts (however, patients who received polypectomy are allowed to enroll). * Has history of severe ovarian hyperstimulation syndrome (OHSS) defined as Grade 4 or higher. * Poor ovarian reponder according to Bologna criteria * Has plans to donate oocyte or recieve embryo from another women or undergo preimplantation genetic testing(PGT) * Has history of three or more failures in previous IVF cycles * Has history of recurrent miscarriage * Has known current active pelvic inflammatory disease. * Is currently breastfeeding. * Has a contraindication to pregnancy that would preclude participation in the trial.

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Conditions

The condition(s) this trial relates to.

female infertility

As listed by the trial registrant

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

Female infertility

Contacts and locations

Locations

  • The first affiliated hospital of Zhengzhou University

    Zhengzhou, China

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