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Infertility, FemaleNCT05698550

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

A study testing Erzhi Tiangui Granule in people with Infertility, Female, run by Shandong University of Traditional Chinese Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 35 to 43 years, women onlyHealthy volunteers can take part
Conditions the study is for
Infertility, Female
What is being tested?
Erzhi Tiangui Granule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
480 participants
Where
1 siteChina
Study dates
15 Sep 2023to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 43 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

    Jinan, Shandong, 250014

Other trials in China

About this study

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

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).

Read the detailed description

In recent years, traditional Chinese medicine (TCM) has been involved with all aspects of assisted reproductive technology (ART), but it remains a long way from being applied to in vitro fertilization and embryo transfer (IVF-ET). Moreover, there is a lack of high-quality clinical research conducted on a large scale. The Erzhi Tiangui formula, which originated from Gui-Cheng Xia, a national TCM master, was composed and established by Professor Fang Lian, who was a national famous TCM practitioner and "Qi Huang scholar," based on her professional experience of more than 40 years. After more than 20 years of basic and clinical investigation, it has demonstrated its effectiveness in optimizing female reproductive function. We therefore adopt Erzhi Tiangui Fang as a pretreatment for IVF-ET in patients with expected poor ovarian response in order to improve their reproductive outcomes. Outpatient clinics at 10 public tertiary hospitals in the country are involved in the study. It is planned to enroll 480 elderly patients with poor ovarian response between January 2023 and December 2025. The Erzhi Tiangui formula group and placebo group will be randomly assigned in a 1:1 ratio through stratified block randomization. Both groups will use a fixed gonadotrophin releasing hormone (GnRH) antagonist protocol for controlled ovarian hyperstimulation. In IVF cycles, Erzhi tiangui formula and placebo will be administered from day 2 or 3 of the previous menstrual cycle to the trigger day. Approximately 5 to 6 weeks will be required for the intervention to be completed. The primary outcome is the number of retrieved oocytes, i.e., the number of oocytes observed under a microscope after oocyte retrieval monitored by transvaginal ultrasound. Secondary outcomes are the ovarian stimulation outcomes, embryonic laboratory outcomes, pregnancy outcomes, obstetric and neonatal outcomes.

Being tested
Erzhi Tiangui Granule, Erzhi Tiangui Placebo
Keywords
Erzhi Tiangui Formula, Poor ovarian response, In Vitro Fertilization and Embryo Transfer (IVF-ET), Advanced maternal age
Medical subject headings
Infertility, Female

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

  • 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.

Study groups in NCT05698550
Study groupRoleWhat they receive
EZTG groupExperimentalNot described
Receives: Drug: Erzhi Tiangui Granule
Control groupPlacebo comparatorNot described
Receives: Drug: Erzhi Tiangui Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Eighteen months

  2. The number of oocyte retrieved

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

    Measured: One month

Secondary outcomes (4)

  1. Cycle cancellation rate

    Cycle cancellation is defined as cycle cancelled before obtaining at least one viable embryo for any reason. And cycle cancellation rate is calculated by dividing the number of women cancelled their cycle before obtaining at least one viable embryo for any reason by the total number of women randomized to the specific group.

    Measured: One month

  2. Number of Metaphase II (MII) oocytes

    MII oocytes is defined as oocytes retrieved that reach the MII phase.

    Measured: One month

  3. The number of good quality embryo

    Good quality embryo is defined as embryo that is graded as 6-cell grade 2 (6CII) or better or blastocyst. And good quality embryo rate is calculated by dividing the number of good quality embryo by the total number of embryo obtained after fertilization in the specific group.

    Measured: One month

  4. Cumulative Clinical pregnancy rate

    Clinical pregnancy will be diagnosed with the detection of an intrauterine gestation sac. And cumulative clinic pregnancy rate is calculated by the number of women who achieves clinical pregnancy after transfers of all study-specific embryos (within 1 year after randomization) by the total number of women randomized to the specific group.

    Measured: Fourteen months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2023
  2. Study start15 Sep 2023
  3. Primary completion30 Jun 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
480 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05698550
Sponsor's protocol ID
SDUTCMEZTG1104
Status last verified
Apr 2026
First submitted
11 Jan 2023
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Erzhi Tiangui Granule in people with Infertility, Female, run by Shandong University of Traditional Chinese Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative live birth rate (time frame: Eighteen months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05698550.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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