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Fibroid removal before IVF: a Game-Changer for fertility?

NCT ID NCT07578623

Disease control Sponsor: Peking Union Medical College Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at whether surgically removing uterine fibroids (myomectomy) before in vitro fertilization (IVF) helps women with infertility have a baby. About 792 women aged 20-39 with fibroids 4-6 cm that do not distort the uterine cavity will be randomly assigned to either have surgery first or go straight to IVF. The main goal is to see if surgery improves the live birth rate within one year after IVF.

What this could mean

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

Active substance
Myomectomy (surgical removal of uterine fibroids)
What this could lead to
If successful, this could show that removing certain fibroids before IVF improves the chance of a live birth, helping guide treatment decisions for infertile women.
What could go wrong
This trial has not started yet, and results may not show a clear benefit. Surgery itself carries risks like infection or scarring, and the fibroids may grow back.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 792 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

20 to 40 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: * Female patients aged 20 years or older and younger than 40 years. * Primary infertility or secondary infertility. Infertility factors may include male partner factors, ovulatory disorders, tubal factors, endometriosis, other non-uterine corpus disease factors, or unexplained infertility. * Pelvic MRI indicating intramural fibroids: FIGO type 4-6; the largest fibroid has a maximum diameter of at least 4 cm and less than 6 cm; a total of no more than two fibroids measuring 4-6 cm; fibroids smaller than 4 cm may be disregarded. * Meets indications for IVF and is willing to undergo IVF treatment. Exclusion Criteria: * Infertility factors related to diseases of the uterine corpus, including but not limited to adenomyosis, intrauterine adhesions, endometritis, submucosal fibroids, and multiple endometrial polyps. A single endometrial polyp 1 cm or smaller does not require exclusion. * Coexisting malignant or borderline tumors of the reproductive system, or other malignant tumors that are untreated or still under treatment. * Active pelvic inflammatory disease. * Previous cytotoxic therapy or pelvic/abdominal radiotherapy or chemotherapy. * Previous surgery of the uterine corpus, including but not limited to myomectomy, uterine wedge resection, uterine artery embolization, tumor coagulation of the uterine corpus such as high-intensity focused ultrasound or electrocoagulation, and hysteroscopic myomectomy. Prior hysteroscopy, diagnostic curettage, or hysteroscopic polypectomy does not require exclusion. * Expected inability to complete follow-up.

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Conditions

The condition(s) this trial relates to.

fibroma infertility disorder leiomyoma uterine corpus leiomyoma

As listed by the trial registrant

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

In vitro fertilization (IVF) Infertility Uterine myomas, leiomyomas, or fibromas

How to take part

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  1. The official record

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    Open the record ↗

  2. A doctor treating you

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