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Sequential Therapy of TCM Herbs to Improve the Success Rate of IVF-ET in Diminished Ovarian Reserve Patients

NCT04842825 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-06-18

No results posted yet for this study

Summary

In the early stage, our team found that traditional Chinese medicine (TCM) intervention aimed at Nourishing kidney and regulating blood circulation in vitro fertilization and embryo transfer(IVF-ET) can improve the clinical pregnancy rate. In order to further study the role of TCM in improving the pregnancy outcome of IVF-ET in infertility due to decreased ovarian reserve (DOR). A randomized controlled clinical trial was used in this study. 200 infertile patients with DOR were randomly divided into two groups. The control group was treated with conventional modern medicine, and the treatment group was treated with traditional Chinese herbs on the basis of conventional modern medicine.

The intervention started from the 5th day of the first menstrual cycles after enrollment and lasted for three months before IVF-ET. After the transplantation, the TCM treatment continues for 14 days. The number of oocytes, antral follicles, anti-Mullerian hormone(AMH), serum follicle-stimulating hormone(FSH), and clinical pregnancy rate will be observed to evaluate the effect of traditional Chinese medicine on the improvement of ovarian function, pregnancy outcome, and fertility of DOR patients.

Conditions

  • Infertility, Female

Interventions

DRUG

Er Zhi Wan combined with Si Wu Tang

The TCM medicines used will be Radix et Rhizoma Ligustrum 15 g, Radix Morindae Sinensis 12 g, Fructus Lycii 15 g, Semen Cuscutae 20 g, Radix Rehmanniae 20 g, Radix Angelicae Sinensis 10 g, Radix Paeoniae Alba 12 g, Radix Yam 20 g. The hospital will be responsible for the decoction of 200 mL per dose, 1 dose per day, divided into 2 doses in the morning and in the evening, for 10-15 days. According to follicular development and endometrial growth monitored by ultrasound, the herbs will be changed to Curculus 10 g, Xianling spleen 15 g, Morinda officinalis 15 g, Cuscutae 20 g, Amethyst 15 g, Rehmannia 20 g, Angelica 15 g, Chuanxiong 10 g，which will be taken for 10-15days. After ET, the treatment group will continue to take Chinese herbal medicine, changing to Cuscuta 15 g, Sambucus 15 g, Chuan Guan Gong 10 g, Agaricus 9 g, Shu Di 15 g, Angelica 10 g, Bai Shao 12 g for 14 days

DRUG

Recombinant Human Follitropin Alfa 、Fructose 、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder

The control group will be treated with conventional Western medicine（The specific drug dose is determined according to the individual level of patients）

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Principal Investigators

  • Dong Li · Peking University Third Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-15
Primary Completion
2022-12-30
Completion
2022-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04842825 on ClinicalTrials.gov