MedTrace Logo

Traditional Chinese Medicine Herbs in the Freeze-all IVF Cycle

NCT04935073 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-06-23

No results posted yet for this study

Summary

In the early stage, the preliminary study found that traditional Chinese medicine (TCM) intervention aimed at Nourishing kidney and regulating blood circulation in freeze-all IVF cycles 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. A randomized controlled clinical trial will be used in this study. 90 infertile patients are randomly divided into two groups. The control group will be treated with conventional modern medicine, and the treatment group will be treated with traditional Chinese herbs on the basis of conventional modern medicine. The intervention starts from the 5th day of the menstrual cycle and lasts until the day before IVF-ET. After the transplantation, the TCM treatment continues for 14 days. The number of oocytes, antral follicles, AMH, serum FSH, and clinical pregnancy rate will be observed to evaluate the effect of TCM herbs on the improvement of pregnancy outcomes. In addition, all the participants will be asked to complete the self-evaluation of the anxiety/depression scale on the 7th day of the menstrual cycle, before and after transplantation, to analyze the emotional changes of the subjects during the study. The study will also observe the safety and health economic indicators of TCM treatment, so as to improve the overall efficacy of TCM Combined Application in assisted reproductive technology in the future.

Conditions

  • Infertility, Female

Interventions

DRUG

Prescription of traditional Chinese Medicine named Er Zhi Wan combined with Si Wu Tang

The medicines used in this study including Radix et Rhizoma Ligustrum 15 g, Radix Morindae Sinensis 12 g, Fructus Lycii 15 g, Semen Cuscutae 20 g, Radix Rehmanniae 15 g, Radix Angelicae Sinensis 10 g, Radix Paeoniae Alba 10 g, Ligusticum wallichii 6 g, Poria cocos 15g, Polygonatum 15g, eclipta 10g. which will be taken for 10-15days.After the ET, the treatment group will continue to take Chinese herbal medicine, changing to Shou Tai pills ( Morinda officinalis 15 g, Teasel 15g，Cuscutae 20 g, Eucommia ulmoides 15 g, Rehmannia 15 g, Cornus officinalis 15 g, loranthus parasiticus 20 g, Ligustrum lucidum 15g, Salvia miltiorrhiza 10g, Scutellaria baicalensis 10g, Atractylodes macrocephala 15g); which will be taken for 14days. 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.

DRUG

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

The intervention starts from the 5th day of the menstrual cycle and lasts to the day before IVF-ET.

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

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
2021-06-15
Primary Completion
2022-12-30
Completion
2022-12-30

More Related Trials

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 NCT04935073 on ClinicalTrials.gov