Efficacy of Traditional Chinese Medicine on Ameliorating IVF-ET Outcomes of Diminished Ovarian Reserve Patients

NCT05577455 | Unknown Phase 3 DMC

• 1 other identifier: IRB00006761-M2022270
• Study Type: interventional
• Target: 266
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with diminished ovarian reserve (DOR) who undergo in vitro fertilization and embryo transfer (IVF-ET) are included as the research subjects. The effects of Traditional Chinese Medicine (TCM) for kidney tonifying and blood circulation regulating of different intervention courses on ovarian hyporesponsiveness, IVF-ET outcome and clinical compliance in DOR patients are studied by a non-inferiority randomized controlled trial. The purpose is to identify the breakthrough point and treatment timing of TCM treatment, explore the best treatment course of TCM, and optimize the TCM therapeutic regimen.

Conditions

Diminished Ovarian Reserve; Infertility, Female

Keywords

traditional Chinese medicine; in vitro fertilization and embryo transfer; diminished ovarian reserve

Outcome Measures

Primary Outcomes (1)

• Number of oocytes retrieved

  The number of oocytes retrieved by puncture under the guidance of vaginal ultrasound

  up to 15 weeks from enrollment

Secondary Outcomes (12)

• High-quality embryo rate (%)

  up to 15 weeks from enrollment

• Clinical pregnancy rate

  up to 15 weeks from enrollment

• Compliance with the treatment plan

  up to 15 weeks from enrollment

• Gonadotrophin (Gn) administration day

  up to 15 weeks from enrollment

• Gn dosage

  up to 15 weeks from enrollment

Study Arms (2)

administration for 2 menstrual cycles group

EXPERIMENTAL

This group will receive TCM treatment before 2 menstrual cycles of IVF-ET.

Drug: Medical prescription before ovulation; Drug: Medical prescription after ovulation

administration for 3 menstrual cycles group

ACTIVE COMPARATOR

This group will receive TCM treatment before 3 menstrual cycles of IVF-ET.

Drug: Medical prescription before ovulation; Drug: Medical prescription after ovulation

Interventions

Medical prescription before ovulation DRUG

Medical prescription before ovulation, modified two solstices pill and Si-Wu-Tang: 15g of Nv Zhen Zi (Fructus Ligustri Lucidi), 10g of Mo Han Lian (Yerbadetajo herb), 15g of Gou Qi Zi (Fructus lycii), 20g of Tu Si Zi (Semen cuscutae), 15g of Shu Di (Radix Rehmanniae Preparata), 10g of Dang Gui (Angelica sinensis), 10g of Bai Shao (Paeonia lactiflora Pallas), 20g of Sheng Shan Yao (Rhizoma Dioscoreae), 15g of Fu Pen Zi (Raspberry), and 15g of Shan Yu Rou (Fructus corni). The medical prescription is initiated on the fifth day of menstruation and is taken continuously for 10-15 days.

administration for 2 menstrual cycles group; administration for 3 menstrual cycles group

Medical prescription after ovulation DRUG

Medical prescription after ovulation, modified Er Xian decoction for promoting fertilization and Si-Wu-Tang: 10g of Xian Mao (Curculigo orchioides), 15g of Xian Ling Pi (Epimedium Herb), 15g of Ba Ji Tian (Morinda officinalis), 20g of Tu Si Zi (Semen cuscutae), 15g of Nv Zhen Zi (Fructus Ligustri Lucidi), 15g of Zi Shi Ying (Fluoritum), 15g of Shu Di (Radix Rehmanniae Preparata), 10g of Dang Gui (Angelica sinensis), 10g of Bai Shao (Paeonia lactiflora Pallas), and 10g of Chuan Xiong (Szechwan Lovage Rhizome). The medical prescription is administered continuously for 10-15 days after ovulation, based on follicle development and endometrial growth monitored by ultrasound.

administration for 2 menstrual cycles group; administration for 3 menstrual cycles group

Eligibility Criteria

• Age: 20 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female, 20 years old ≤ age ≤ 42 years old;
• The menstrual cycle is generally regular; 21 days \< menstrual cycle \< 35 days;
• Those who meet the diagnostic criteria for DOR in Western medicine;
• Those who meet the TCM differential criteria of kidney deficiency syndrome;
• Those who are scheduled to undergo IVF-ET;
• Those who voluntarily participate in this clinical trial and sign a written informed consent.

You may not qualify if:

• Those who have a history of two or more spontaneous abortions (excluding biochemical pregnancy abortion) or three or more previous transplantations without achieving clinical pregnancy;
• Those who have premature ovarian failure or ovarian gonadotropin resistance syndrome;
• Those who have untreated uterine malformation or abnormality: double uterus, septate uterus (complete or incomplete);
• Those who have untreated unilateral or bilateral hydrosalpinx;
• Those who have uncured endometrial diseases (such as endometritis, endometrial polyps, endometriosis), adenomyosis, intrauterine adhesions, etc., and those with uterine fibroids of more than 4 cm;
• Those who have endocrine diseases such as polycystic ovary syndrome, hyperprolactinemia, hyperandrogenism, hypothyroidism, abnormal adrenal function, etc., which affect ovulation;
• Infertile patients with abnormal ovarian function caused by immunological factors, genetic factors or congenital physiological defects;
• Those who have received pelvic radiotherapy;
• Those who are known or suspected of having sex hormone-related malignant tumors;
• Those who are allergic or intolerable to the medications involved in the study;
• Those with contraindications to assisted reproductive technology or pregnancy, such as uncontrolled abnormal liver and renal function, diabetes, hypertension, thyroid disease, symptomatic heart disease, moderate to severe anemia, history of malignant tumor or history of thromboembolism or thrombosis formation tendency, serious mental illness, acute infection of urogenital system, sexually transmitted disease, extremely bad habits such as drug use, exposure to teratogenic radiation, poison, drugs (such as prednisone and other hormones, epinephrine, antibiotics, antihypertensive drugs, cardiovascular and cerebrovascular drugs, antiviral drugs) and are still under the effect of the drugs; and those whose uterus is unable to perform the function of pregnancy or who are intolerant of pregnancy due to physical diseases during pregnancy;
• Those who have taken other TCMs or proprietary Chinese medicines that can invigorate the kidney or affect the evaluation of drug efficacy in the past 30 days;
• Other patients who are deemed unsuitable to participate in this study by the researchers;
• Those who are participating in other clinical trials;
• Those who do not agree to participate in this study or do not sign the informed consent form.

Sponsors & Collaborators

• Peking University Third Hospital: lead

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

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

Study Officials

• Dong Li

  Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

Xiyan Xin

CONTACT

+86 0108226; xinxiyan198234@163.com

Study Design

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

Model Details: After the patients complete the relevant examinations, and those who meet the inclusion criteria sign the informed consent, they are sequentially assigned to two groups according to the randomization table. The intervention begins from the second menstrual cycle prior to IVF-ET in the experimental group and third menstrual cycle prior to IVF-ET in the control group. TCM treatment is initiated on the 5th day of menstruation in both groups, and medical prescriptions before and after ovulation are administered successively. Subjects do not take any medicine on the 1st to 4th day of menstruation and medications are discontinued on the day of HCG. The TCM is decocted by our hospital, and patients are instructed to take one dose of the the decoction warm per day (400 ml per dose) one hour after meals twice (once in the morning and once in the evening). The occurrence of spontaneous pregnancy and adverse reactions are recorded and dealt with promptly throughout the drug application period.

Study Record Dates

• First Submitted: October 9, 2022
• First Posted: October 13, 2022
• Study Start: November 10, 2022
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: October 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share