NCT05698550

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

September 15, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.8 years

First QC Date

January 11, 2023

Last Update Submit

April 6, 2026

Conditions

Infertility, Female

Keywords

Erzhi Tiangui FormulaPoor ovarian responseIn Vitro Fertilization and Embryo Transfer (IVF-ET)Advanced maternal age

Outcome Measures

Primary Outcomes (2)

  • Cumulative live birth rate

    Cumulative live birth rates (CLBR), defined as the proportion of deliveries with at least one live birth per started cycle or per oocyte aspiration, including all fresh and/or frozen embryo transfers until one delivery with a live birth or until all embryos were used.

    Eighteen months

  • The number of oocyte retrieved

    After oocyte retrieval by transvaginal puncture, the number of collected oocytes was observed microscopically.

    One month

Secondary Outcomes (4)

  • Cycle cancellation rate

    One month

  • Number of Metaphase II (MII) oocytes

    One month

  • The number of good quality embryo

    One month

  • Cumulative Clinical pregnancy rate

    Fourteen months

Study Arms (2)

EZTG group

EXPERIMENTAL
Drug: Erzhi Tiangui Granule

Control group

PLACEBO COMPARATOR
Drug: Erzhi Tiangui Placebo

Interventions

Erzhi Tiangui GranuleDRUG

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.

EZTG group
Erzhi Tiangui PlaceboDRUG

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.

Control group

Eligibility Criteria

Age35 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Women aged 35 to 43 years with POR who were scheduled for IVF or intracytoplasmic sperm injection (ICSI) treatment were eligible for enrollment. The diagnosis of POR was based on the Bologna criteria. Women were excluded if they: (i) had a body mass index (BMI) ≥ 35 kg/m2; (ii) failed to obtain clinical pregnancy after three or more IVF/ICSI cycles; (iii) had a history of two or more recurrent pregnancy losses; (iv) were diagnosed with uterine abnormalities using hysteroscopy or diagnosed with hydrosalpinx using hysterosalpingography; (v) had a history of chemotherapy with cytotoxic agents, pelvic radiotherapy, or severe systemic diseases; (vi) had taken Chinese herbal medicines or other therapies affecting ovarian function within three months before study enrollment; or (vii) were allergic to the ingredients of EZTG granules or placebo.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, 250014, China

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 11, 2023

First Posted

January 26, 2023

Study Start

September 15, 2023

Primary Completion

June 30, 2025

Study Completion

December 31, 2025

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

CN(1)