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Can an ancient herbal remedy boost IVF pregnancy rates?

NCT ID NCT07347340

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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.
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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 Results may not be published yet.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

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Status unknown
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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This clinical trial tests whether a traditional Chinese herbal formula, Bushen Tongzhi, can improve pregnancy rates in women with diminished ovarian reserve who are undergoing IVF. About 348 women aged 22-39 will take either the herbal granules or a placebo three times daily for up to 6 months before and during their IVF cycle. The study aims to see if the herbal pretreatment leads to more clinical pregnancies compared to placebo.

What this could mean

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

Active substance
Bushen Tongzhi Formula (a traditional Chinese herbal granule)
What this could lead to
If it works, this could offer a safe, low-cost pretreatment to improve IVF success for women with diminished ovarian reserve.
What could go wrong
This is a phase 3 trial, but herbal remedies often show mixed results in rigorous testing. The benefit may be small or no better than placebo, and individual responses can vary.

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 348 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jun 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: * Women aged 22 to 39 years (inclusive). * Diagnosis of diminished ovarian reserve (DOR), defined by meeting at least two of the following three criteria: 1, Basal follicle-stimulating hormone (FSH) level between 10 and 25 IU/L (measured on menstrual cycle days 2-4); 2, Anti-Müllerian hormone (AMH) level \< 1.1 ng/mL; 3, Antral follicle count (AFC) \< 7 (total count of follicles 2-10 mm in diameter in both ovaries). * Diagnosis of infertility, defined as failure to achieve a clinical pregnancy after 12 months or more of regular unprotected sexual intercourse. * Diagnosis of Kidney Deficiency pattern according to Traditional Chinese Medicine criteria, as defined in the study protocol. * Scheduled to undergo a fresh in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle. * Willing and able to provide written informed consent. Exclusion Criteria: * Uterine structural abnormalities likely to impair implantation or pregnancy (e.g., untreated submucosal fibroids, severe intrauterine adhesions, uterine septum). * Known abnormal karyotype in either partner. * Uncontrolled or severe medical conditions (e.g., hypertension, diabetes, thyroid dysfunction, hepatic/renal insufficiency, symptomatic heart disease). * Diagnosed severe psychiatric disorders (e.g., schizophrenia, bipolar disorder). * History of prior pelvic radiation or cytotoxic chemotherapy. * Active genital tract infection. * Diagnosed or suspected severe (ASRM stage III-IV) endometriosis with recurrent symptoms. * Planned use of donor oocytes or preimplantation genetic testing (PGT). * History of repeated IVF/ICSI failure (≥3 failed egg retrieval cycles or ≥3 failed transfers of high-quality embryos). * Known allergy to any component of the investigational herbal formula. * Participation in another clinical trial within the past 3 months. * Use of medications known to affect ovarian function (e.g., DHEA, growth hormone) within the past month. * Current heavy alcohol consumption or smoking. * Any other condition deemed by the investigator to make the participant unsuitable for the study.

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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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

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  3. A doctor treating you

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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.