MedTrace Logo

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

NCT07347340 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2026-01-16

No results posted yet for this study

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)

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
39 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2028-01-31
Completion
2028-06-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07347340 on ClinicalTrials.gov