Traditional Chinese Medicine Herbs in the Freeze-all IVF Cycle

NCT04935073 | Unknown Phase 3

• 1 other identifier: IRB00006761-M2020442
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

infertility; traditional chinese medicine; freeze-all IVF cycle; Embryo Transfer

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy rate (%)

  Follow up by telephone calls 14days after the IVF-ET

  up to 6 weeks from enrollment

Secondary Outcomes (1)

• Concentration of β-human Choriogonadotropin(β-HCG)

  up to 6 weeks from enrollment

Other Outcomes (2)

• Changes from Baseline concentration of Self rating Anxiety Scale (SAS)

  The 5th day of menstruation、 immediately before the proposed IVF-ET procedure、14 days after the IVF-ET

• Changes from Baseline concentration of Self rating Depression Scale (SDS)

  The 5th day of menstruation、 immediately before the proposed IVF-ET procedure、14 days after the IVF-ET

Study Arms (2)

Traditional Chinese Medicine herbs treatment group

EXPERIMENTAL

the treatment group will receive treatment with the Chinese herbal formula on the 5th day of the menstrual cycle and lasts to 14 days after IVF-ET.

Drug: Prescription of traditional Chinese Medicine named Er Zhi Wan combined with Si Wu Tang; Drug: Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for Injection

Western medicine group

ACTIVE COMPARATOR

The control group will be treated with conventional Western medicine

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

Interventions

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

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.

Also known as: conventional western medicine(Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for Injection )

Traditional Chinese Medicine herbs treatment group

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

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

Traditional Chinese Medicine herbs treatment group; Western medicine group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Meet the diagnostic criteria for infertility.
• Meet the criteria for identifying kidney deficiency in TCM.
• Patients who Planning to undergo IVF-ET for pregnancy in our center, Age ≤40 years and ≥25 years.
• Previous embryo transfer failure ≥ 2 times.
• Menstrual cycle is basically normal, and normal ovulation has been monitored in the past.
• There were more than 1 blastocyst /more than 2 high-quality embryos with more than 6 cells on day 3/more than 2 high-quality embryos with more than 4 cells on day 2.
• Consent to participate in this clinical trial and sign an informed consent form.

You may not qualify if:

• Patients with endometritis, acute pelvic inflammatory disease, mycotic vaginitis, bacterial vaginitis, adnexitis or other systemic infections.
• It has been confirmed that there are obvious and serious other organic lesions in the reproductive organs.
• Patients with allergic constitution
• Infertility caused by genetic factors
• Patients with serious primary diseases such as cardio cerebrovascular, kidney, liver and hematopoietic system and psychosis
• A person who is unable to cooperate (such as a combination of neurological or mental illness, or a reluctance to cooperate)
• The endometrial thickness on the day of hCG was less than 6 mm or the endometrial morphology on the day of hCG was type C
• Those who did not agree to participate in the study

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Conditions

Infertility, Female; Infertility

Interventions

si-wu-tang; Injections

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

xiyan Xin

CONTACT

+86 0108226-4621; xinxiyan198234@163.com

Ruiwen Fan

CONTACT

frw9606@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2021
• First Posted: June 22, 2021
• Study Start: June 15, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: June 23, 2021

Record last verified: 2021-06