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

Starting soon · Phase 3 · Has a placebo group

Conditions studied: Diminished Ovarian Reserve (DOR)

In brief

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.

Key facts

Study ID

NCT07347340

Run by

Peking Union Medical College Hospital

People needed

348

Starts

2026-01-01

Expected to finish

2028-06-01

Last updated by the study team

2026-01-16

Who can join

Age: 22 and older, up to 39. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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