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The Role of Erzhi Tiangui Formula in Expected POR Women Undergoing IVF-ET
Sponsor: Shandong University of Traditional Chinese Medicine
Summary
This randomized controlled trial aims to determine whether Erzhi Tiangui Formula can optimize the reproductive outcomes of elderly patients with expected poor ovarian response, and to provide a new approach to traditional Chinese medicine assisted in vitro fertilization and embryo transfer (IVF-ET).
Official title: Efficacy of Erzhi Tiangui Granules on Live Birth Rate in Advanced-age Women With Poor Ovarian Response Undergoing in Vitro Fertilization: A Multicenter, Randomized, Double-blind, Placebo-controlled Trial
Key Details
Gender
FEMALE
Age Range
35 Years - 43 Years
Study Type
INTERVENTIONAL
Enrollment
480
Start Date
2023-09-15
Completion Date
2025-12-31
Last Updated
2026-04-13
Healthy Volunteers
Yes
Conditions
Interventions
Erzhi Tiangui Granule
The Drug Manufacturing Unit of the Affiliated Hospital of Shandong University of Traditional Chinese Medicine produced the EZTG granule.The EZTG was packaged as 3 g/bag, batch number 01-FZ032-03. The daily dose is equivalent to 15g of Ligustrum lucidum (Nv Zhen Zi),15g of Lotus japonicus (Han Lian Cao),15g of the fruit of Chinese wolfberry(Gou Qi Zi),15g of Cuscuta chinensis(Tu Si Zi), 15g of Radix Rehmanniae Preparata(Shu Di Huang),12g of Angelica sinensis(Dang Gui),12g of Paeonia lactiflora(Bai Shao),12g of Ligusticum wallichii(Chuan Xiong),12g of Rhizoma cyperi(Xiang Fu),and 9g of Radix Glycyrrhizae (Zhi Gan Cao).The placebo granule,which was Preparata mainly composed of dextrin, was made in a similar color and shape to EZTG.Placebo granules were packaged as 3g/bag, with the same package of the EZTG, batch number 01-FZ032-03-1. The EZTG or placebo was orally administered after being dissolved in water, 3g each time, 3 times a day.
Erzhi Tiangui Placebo
The placebo consisted mainly of yellow bean powder, starch, carbogen, molasses and could mimic the appearance, color and smell of Erzhi Tiangui granules, but without any active ingredients. Daily doses of placebo were delivered in the same packaging as Erzhi Tiangui granules.
Locations (1)
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China