Not Yet RecruitingPhase 3

Testing Herbal Pretreatment For IVF Success In Women With Low Ovarian Reserve

China348 participantsStarted 2026-01-01

Plain-language summary

The goal of this clinical trial is to learn if a traditional Chinese herbal pretreatment can improve pregnancy outcomes in infertile women with diminished ovarian reserve (DOR) who are undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). The main question it aims to answer is: • Does pretreatment with the Bushen Tongzhi Formula increase the cumulative clinical pregnancy rate from a single egg retrieval cycle compared to a placebo? Researchers will compare the group taking the herbal formula to the group taking a placebo to see if the herbal formula is more effective. Participants will: * Take the assigned study medication (herbal formula or placebo) three times daily for 3 months before starting IVF/ICSI. * Continue taking the medication during their IVF/ICSI treatment cycle, for up to 6 months total. * Undergo standard IVF/ICSI procedures as planned by their doctor. * Have their pregnancy outcomes and health monitored through clinic visits and their medical records.

Who can participate

Age range

22 Years – 39 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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) endo…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Cumulative clinical pregnancy rate from a single oocyte retrieval cycle

Timeframe: From randomization until 12 months after the oocyte retrieval procedure.

Trial details

NCT IDNCT07347340

SponsorPeking Union Medical College Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-31

Contact for this trial

Wei xue

+8619529291280 xuewei@pumch.cn

View on ClinicalTrials.gov More Diminished Ovarian Reserve (DOR) trials