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Ancient herbs meet modern medicine in new fertility trial for women with low egg reserve

NCT ID NCT07296614

Disease control Sponsor: Peking Union Medical College Hospital 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial will test whether adding a traditional Chinese herbal formula to the standard fertility drug letrozole can improve natural pregnancy rates in women aged 22–39 with diminished ovarian reserve (low egg supply). The study plans to enroll 320 women who will receive either the combined treatment or a placebo plus letrozole. The main goal is to see if more women achieve a confirmed pregnancy within the study period.

What this could mean

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

Active substance
Letrozole and Xiehe DOR Kidney-Tonifying Universal Formula (Chinese herbal granules)
What this could lead to
If successful, this combination therapy could offer a new, non-invasive option to help women with diminished ovarian reserve conceive naturally without IVF.
What could go wrong
This is a Phase 3 trial, but it has not yet started recruiting. The herbal formula is specific to Chinese medicine diagnosis, so results may not apply to all women. There is also a risk the placebo group performs similarly.

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 320 people

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

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Jul 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

22 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: 1. Female patients aged 22 to 39 years (inclusive). 2. Meet the diagnostic criteria for diminished ovarian reserve (requiring at least two of the following: Basal FSH 10-25 IU/L; AMH \< 1.1 ng/mL; AFC \< 7) and infertility(defined as the failure to achieve pregnancy after 12 months of regular unprotected sexual intercourse). 3. Meet the diagnostic criteria for kidney deficiency syndrome in traditional Chinese medicine 4. Voluntarily participate in this study and provide written informed consent. Exclusion Criteria: 1. Patients with premature ovarian insufficiency or premature ovarian failure (basal FSH \>25 IU/L), organic pathologies such as ovarian tumors, endometrial tuberculosis, intrauterine adhesions, or endometrial injuries, as well as those with congenital adrenal hyperplasia or Cushing's syndrome; 2. Infertility caused by organic lesions of the fallopian tubes, uterus, cervix, etc. 3. Infertility due to male factors (based on semen analysis reports, meeting the diagnostic criteria for oligoasthenoteratozoospermia according to the WHO 5th edition standards). 4. DOR caused by iatrogenic factors (such as pelvic surgery, radiotherapy/chemotherapy, uterine artery embolization, etc.). 5. Patients with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems, or psychiatric disorders. 6. Individuals with known allergies to the investigational drug or its components. 7. Use of hormonal medications (e.g., estrogen, contraceptive drugs) within one month prior to enrollment, or use of kidney-tonifying Chinese herbal medicines or proprietary Chinese medicinal products within one month prior to enrollment. 8. Patients currently participating in or planning to participate in other clinical trials.

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Conditions

The condition(s) this trial relates to.

infertility disorder ovarian dysfunction

As listed by the trial registrant

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

Diminished ovarian reserve (DOR) Infertility

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

    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

  • Peking union medical college hospital

    Beijing, Beijing Municipality, 100730, China

More trials for these conditions

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