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Could a simpler hormone regimen boost IVF success? new trial investigates

NCT ID NCT06644794

Disease control Sponsor: Shandong University of Traditional Chinese Medicine Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial compares two ways to prepare the womb lining for a frozen embryo transfer: a modified natural cycle using progesterone only, versus standard hormone replacement therapy. The study will enroll 336 women aged 21-44 with regular cycles to see which method leads to more live births. The modified natural cycle aims to be more convenient and potentially safer by reducing the need for monitoring and lowering pregnancy complications.

What this could mean

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

Active substance
Progesterone and estradiol (hormone therapies)
What this could lead to
If this trial succeeds, it could show that a simpler, more natural hormone preparation method leads to more live births and fewer pregnancy complications for women undergoing frozen embryo transfer.
What could go wrong
This is a phase 3 trial, but it is still relatively small (336 participants) and focuses on a specific group of women with regular cycles. Results may not apply to all infertility patients, and the new method may not prove superior.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 336 people

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

Started

Mar 2025

Expected to finish

Dec 2028

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

21 to 44 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: * Patients aged 21 to 44 years undergoing FBT * Body mass index (BMI) 18-35 kg/m2 * Having regular ovulatory cycles Exclusion Criteria: * Untreated uterine adhesions * Medical contraindications to estrogen and progesterone therapy * Illnesses contraindicating assisted reproductive technology or pregnancy * History of recurrent implantation failures (\> 2 embryo transfer failures)

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Conditions

The condition(s) this trial relates to.

female infertility infertility disorder

As listed by the trial registrant

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

Infertility, female

How to take part

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

  1. The places running it

    1 site. 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

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Contacts and locations

Locations

  • Affiliated Hospital of Shandong University of Traditional Chinese Medicine

    RECRUITING

    Jinan, Shandong, 250014, China

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