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NCT07347340

PHASE3

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

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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.

Official title: Effectiveness Of Bushen Tongzhi Formula Pretreatment On Pregnancy Outcomes In Infertile Women With Diminished Ovarian Reserve Undergoing In Vitro Fertilization And Embryo Transfer: Study Protocol For A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial (PRIME Study)

Key Details

Gender

FEMALE

Age Range

22 Years - 39 Years

Study Type

INTERVENTIONAL

Enrollment

348

Start Date

2026-01-01

Completion Date

2028-06-01

Last Updated

2026-01-16

Healthy Volunteers

Conditions

Diminished Ovarian Reserve (DOR)

Interventions

DRUG

Bushen Tongzhi Formula

Bushen Tongzhi Formula is a standardized, fixed-composition herbal formula developed based on Traditional Chinese Medicine (TCM) principles for treating diminished ovarian reserve due to kidney deficiency. It is composed of multiple herbal ingredients processed into a granulated formulation. The dosage is 20g of granules taken orally three times daily. It serves as the active comparator against an indistinguishable placebo in this trial.

DRUG

Placebo Pretreatment plus Standard IVF/ICSI

Intervention: Participants in this arm receive the control treatment, consisting of an oral placebo combined with a standard IVF/ICSI protocol. Details: Medication: Matched placebo granules. These contain no active herbal ingredients and are formulated from inert materials (e.g., dextrin, food-grade flavorings/colorants) to precisely mimic the appearance, taste, smell, and packaging of the active Bushen Tongzhi Formula granules. Dosage \& Administration: 20g (one sachet), taken orally three times daily after meals. Treatment Regimen: The regimen is identical to the experimental arm: a 3-month pretreatment phase, followed by continued placebo intake concurrently throughout the subsequent IVF/ICSI treatment cycle. The maximum total duration is 6 months, with medication stopping upon confirmation of clinical pregnancy. Concurrent Procedure: Participants undergo the same standard, clinic-directed IVF/ICSI procedures.

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.

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China