The Role of Erzhi Tiangui Formula in Expected POR Women Undergoing IVF-ET

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).

Conditions

• Infertility, Female

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

• 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China

  collaborator OTHER

• First Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• Shanxi Provincial Maternity and Children's Hospital

  collaborator OTHER

• Maternity and Child Health Care of Zaozhuang

  collaborator UNKNOWN

• Yantai Shan Hospital

  collaborator UNKNOWN

• Maternal and Child Health Care Hospital of Shandong Province

  collaborator UNKNOWN

• Hospital for Reproductive Medicine Affiliated to Shandong University

  collaborator UNKNOWN

• Chongqing Medical Center for Women and Children

  collaborator OTHER

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• Shandong University of Traditional Chinese Medicine

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

35 Years

Max Age

43 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-09-15

Primary Completion

2025-06-30

Completion

2025-12-31

Countries

• China

Study Locations