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

NCT07347340 | Not Yet Recruiting Phase 3 DMC

• 2 other identifiers: K92182025-PUMCH-C-020
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diminished Ovarian Reserve (DOR)

Keywords

Traditional Chinese Medicine; Bushen Tongzhi Formula; Diminished Ovarian Reserve; Infertility; In Vitro Fertilization; Randomized Controlled Trial; Multicenter Study; Herbal Medicine; Adjuvant Therapy; Ovarian Response; Pregnancy Rate; Kidney Deficiency; Chinese Medicine Pattern; PRIME Study

Outcome Measures

Primary Outcomes (1)

• Cumulative clinical pregnancy rate from a single oocyte retrieval cycle

  This outcome measures the proportion of participants in each treatment group who achieve a clinical pregnancy resulting from a single oocyte retrieval procedure. A clinical pregnancy is defined as the ultrasound confirmation of an intrauterine gestational sac with cardiac activity. The rate is "cumulative" because it includes pregnancies achieved from both the initial fresh embryo transfer and any subsequent frozen-thawed embryo transfer(s) utilizing all embryos derived from that single retrieval cycle. Data will be collected until no embryos from the index cycle remain for transfer or a clinical pregnancy is confirmed.

  From randomization until 12 months after the oocyte retrieval procedure.

Study Arms (2)

Bushen Tongzhi Formula Pretreatment plus Standard IVF/ICSI

EXPERIMENTAL

Intervention: Participants in this arm receive the investigational treatment, which consists of oral administration of the Bushen Tongzhi Formula granules combined with a standard IVF/ICSI protocol. Details: Medication: "Bushen Tongzhi Formula" herbal granules (20g per dose). Dosage \& Administration: 20g (one sachet), taken orally three times daily after meals. Treatment Regimen: The intervention includes a 3-month pretreatment phase prior to the start of ovarian stimulation. Participants continue taking the medication concurrently throughout their subsequent IVF/ICSI treatment cycle (including during gonadotropin stimulation and until pregnancy confirmation). The maximum total treatment duration is 6 months, stopping upon confirmation of clinical pregnancy. Concurrent Procedure: All participants undergo a standard, clinic-determined controlled ovarian stimulation protocol for IVF or ICSI, followed by egg retrieval, embryo culture, and fresh or frozen-thawed embryo transfer.

Drug: Bushen Tongzhi Formula

Placebo Pretreatment plus Standard IVF/ICSI

PLACEBO COMPARATOR

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.

Drug: Placebo Pretreatment plus Standard IVF/ICSI

Interventions

Bushen Tongzhi Formula DRUG

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.

Bushen Tongzhi Formula Pretreatment plus Standard IVF/ICSI

Placebo Pretreatment plus Standard IVF/ICSI DRUG

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.

Placebo Pretreatment plus Standard IVF/ICSI

Eligibility Criteria

• Age: 22 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Wei xue

CONTACT

+8619529291280; xuewei@pumch.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The data manager and the statistician performing the interim and primary analyses are also masked to group assignment until after the database is locked for the final analysis. This ensures blinding is maintained throughout the data processing and analysis phases to prevent bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment. Participants are randomly assigned to one of two treatment groups (herbal formula or placebo) in a 1:1 ratio and remain in that group for the duration of the intervention. Triple (Participant, Care Provider, Outcomes Assessor). The study is double-blind, meaning neither the participants nor the investigators know the treatment assignment. Outcomes assessors (e.g., embryologists, sonographers) are also blinded. This is achieved using a matched, indistinguishable placebo. The primary purpose is Treatment, to evaluate the efficacy of the herbal intervention compared to placebo.

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 16, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 16, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)