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

NCT04842825 | Unknown Phase 3 DMC

• 1 other identifier: IRB00006761-M2020368
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

infertility; traditional chinese medicine; ovarian reserve; Fertilization in Vitro; Embryo Transfer

Outcome Measures

Primary Outcomes (4)

• Number of eggs obtained

  Obtained by blood sampling before the proposed IVF-ET

  up to 15 weeks from enrollment

• Change from Baseline concentration of Serum anti-Mullerian hormone(AMH) before the proposed IVF-ET

  Obtained by blood sampling before taking TCM herbs and before the proposed IVF-ET

  The 5th day of menstruation in the month of enrollment and Before the proposed IVF-ET（up to 15 weeks from the enrollment）

• Change from Baseline concentration of Serum follicle-stimulating hormone (FSH) before the proposed IVF-ET

  Obtained by blood sampling before taking TCM herbs and before the proposed IVF-ET

  The 5th day of menstruation in the month of enrollment and Before the proposed IVF-ET（up to 15 weeks from the enrollment）

• Clinical pregnancy rate (%): number of clinical pregnancies/total number of ET cycles

  Follow up by telephone calls 30days after the IVF-ET

  up to 19 weeks from the enrollment

Secondary Outcomes (9)

• Change from Baseline concentration of antral follicle count(AFC) before the proposed IVF-ET

  The 5th day of menstruation in the month of enrollment and Before the proposed IVF-ET（up to 15 weeks from the enrollment）

• Concentration of follicular E2 level on the day of human chorionic gonadotropin(hCG) injection

  up to 15 weeks from enrollment

• Change from Baseline concentration of Serum luteinising hormone(LH) before the proposed IVF-ET

  The 5th day of menstruation in the month of enrollment and Before the proposed IVF-ET（up to 15 weeks from the enrollment）

• Quality egg rate (%)

  up to 15 weeks from enrollment

• Total amount of ovulation-promoting drugs

  up to 15 weeks from enrollment

Study Arms (2)

kidney-tonifying and blood-regulating herbs treatment group

EXPERIMENTAL

the treatment group will receive sequential treatment with the Chinese herbal formula for tonifying the kidney, nourishing the blood, and activating the blood 2 months before the proposed ET to regulate menstruation and improve ovarian reserve function. Treatment with the Chinese herbal formula will continue on the 5th day of menstruation after entering the super-ovulation cycle.

Drug: Er Zhi Wan combined with Si Wu Tang

Western medicine group

ACTIVE COMPARATOR

The control group will be treated with conventional Western medicine

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

Interventions

Er Zhi Wan combined with Si Wu Tang DRUG

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

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

kidney-tonifying and blood-regulating herbs treatment group

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

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

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

Western medicine group

Eligibility Criteria

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

You may qualify if:

• Consent to participate in this clinical trial and sign an informed consent form.
• Age ≤40 years, regular menstrual cycle between 21and 35 days in length.
• Meet the Western diagnostic criteria for DOR.
• Meet the criteria for identifying kidney deficiency in Chinese medicine.
• Planning to undergo IVF-ET for pregnancy.

You may not qualify if:

• History of two or more previous spontaneous abortions (excluding biochemical pregnancy abortions) or three or more previous ETs without obtaining a clinical pregnancy.
• Premature ovarian failure or ovarian gonadotropin resistance syndrome.
• Untreated uterine anomalies or abnormalities, including double uterus or longitudinal uterus (complete or incomplete).
• Untreated hydrocele on one or both fallopian tubes (confirmed by hysterosalpingography).
• Uterine adhesions, endometriosis, adenomyosis, endometrial lesions (submucosal fibroids, endometrial polyps, etc.), or uterine fibroids \>4 cm.
• Endocrine disorder affecting ovulation, such as polycystic ovary syndrome, hyperprolactinaemia, hyperandrogenaemia, hypothyroidism, or adrenal abnormalities.
• Infertility with abnormal ovarian function due to immune factors, genetic factors, or congenital physical defects.
• Previous pelvic radiotherapy.
• Known or suspected sex hormone-related malignancy.
• Allergy to or intolerance of the drugs used in the study.
• Combined contraindications to assisted reproductive technology or pregnancy, such as uncontrolled abnormalities of liver and kidney function, diabetes mellitus (glycosylated haemoglobin ≤7%, fasting blood glucose \<10 mmol/L ), hypertension, thyroid disease, symptomatic heart disease, moderate to severe anaemia, history of malignancy or thromboembolism or propensity to thrombosis, severe psychiatric disorder, acute infections of the genitourinary system, sexually transmitted diseases, serious adverse habits such as drug abuse, exposure to teratogenic amounts of radiation, toxins, or drugs (such as prednisone or other hormones, adrenaline, antibiotics, or hypertension, cardiovascular, or antiviral medications) during the active procedure period , and uterine factor infertility or physical illness which prevents the ability to bear a pregnancy.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China, China

RECRUITING

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

Study Officials

• Dong Li

  Peking University Third Hospital

  STUDY CHAIR

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

Model Details: To further investigate its role in improving pregnancy outcomes of IVF-ET in diminished ovarian reserve (DOR) infertility, in this randomized, controlled clinical trial, 200 patients with DOR infertility who intended to undergo IVF-ET will be randomly divided into two groups: a treatment group (Western conventional treatment + kidney-tonifying and blood-regulating herbs) and a control group (Western treatment only). The intervention will be started from the 5th day of menstruation for two menstrual cycles before undergoing IVF-ET until 14 days after transfer.

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: April 13, 2021
• Study Start: April 15, 2021
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)