Clinical Trial

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

Study acronym: PRIME
Not Yet Recruiting Phase 3
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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.
Trial Details
NCT Number NCT07347340
Lead Sponsor Peking Union Medical College Hospital
Conditions Diminished Ovarian Reserve (DOR)
Enrollment 348 participants
Start Date 2026-01-01
Primary Completion 2028-01-31 (estimated)
Study Completion 2028-06-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-16