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| Name | Class |
|---|---|
| 960th Hospital of Joint Logistics Support Force of People's Liberation Army of China | OTHER |
| First Affiliated Hospital of Wenzhou Medical University | OTHER |
| Shanxi Provincial Maternity and Children's Hospital |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EZTG group | Experimental |
| |
| Control group | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erzhi Tiangui Granule | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One month |
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Shandong University of Traditional Chinese Medicine | Jinan | Shandong | 250014 | China |
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| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Maternity and Child Health Care of Zaozhuang | UNKNOWN |
| Yantai Shan Hospital | UNKNOWN |
| Maternal and Child Health Care Hospital of Shandong Province | UNKNOWN |
| Shandong University | OTHER |
| Chongqing Medical Center for Women and Children | OTHER |
| The Second Hospital of Hebei Medical University | OTHER |
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| Erzhi Tiangui Placebo | Drug | 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. |
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| Number of Metaphase II (MII) oocytes | MII oocytes is defined as oocytes retrieved that reach the MII phase. | One month |
| 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. | One month |
| 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. | Fourteen months |
| D000091662 | Genital Diseases |
| D007246 | Infertility |