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RECRUITING

NCT04872660

PHASE4

Efficacy and Safety of Gushen Antai Pill on Ongoing Pregnancy Rate in Women With Normal Ovarian Reserve Undergoing IVF-ET

Sponsor: Shandong University of Traditional Chinese Medicine

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate whether oral Gushen Antai pills supplementation for luteal phase support will improve ongoing pregnancy rate in women with normal ovarian reserve in fresh embryo transfer cycles.

Official title: Efficacy and Safety of Gushen Antai Pill on Ongoing Pregnancy Rate in Women With Normal Ovarian Reserve Undergoing in Vitro Fertilization Embryo Transfer: A Prospective, Multicentre, Randomised, Double-blind, Placebo-controlled Trial

Key Details

Gender

FEMALE

Age Range

21 Years - 42 Years

Study Type

INTERVENTIONAL

Enrollment

800

Start Date

2021-06-15

Completion Date

2026-12-30

Last Updated

2026-03-10

Healthy Volunteers

Conditions

Infertility, Female

Interventions

DRUG

Gushen Antai Pill

The Gushen Antai Pill (GSATP, Z20030144) is composed of 10 herbs including radix-polygoni multiflori, radix rehmanniae praeparata, cistanche salsa, radix dipsaci, uncaria, semen cuscutae, rhizoma atractylodis macrocephalae, radix scutellariae, radix paeoniae lactiflorae. Its production follows GMP standards and takes the form of water honey pills, each bag of 6g.

DRUG

Placebo pill

The placebo pill is produced by Beijing boran Pharmaceutical Co., Ltd. It can simulate the appearance, color and smell of GSATP formula, but it has no clinical effect because it has no active ingredients.

Inclusion Criteria: * Patients with normal ovarian function reserve (5 ≤ AFC ≤ 15, 1.2 ng/ml ≤ AMH ≤ 3.5 ng/ml). * Patients with regular menstrual cycle (21-35 days) and normal ovulation. * Initial IVF / ICSI treatment. * At least one embryo or blastocyst available for transfer. Exclusion Criteria: * Age ≥ 43 years old. * Body mass index (BMI) ≥ 28 Kg/m2. * "Freeze-all" strategy. * Those using the natural cycle or mild stimulation for IVF/ICSI treatment. * Individuals with severe hyperstimulation ovarian syndrome during controlled ovarian stimulation. * Acceptors of donated oocytes or performed either In vitro Maturation (IVM) or blastocyst biopsy for Preimplantation Genetic Diagnosis (PGD) or Preimplantation Genetic Testing for Aneuploidies (PGT-A). * History of two or more previous consecutive spontaneous abortions. * History of two or more previous IVF-ET failures. * Karyotype abnormalities. * Polycystic ovary syndrome. * Presence of a non-surgically treated hydrosalpinx, uterine cavity fluid or endometrial polyp and an ovarian endometriosis cyst requiring surgery, during ovarian stimulation. * Congenital or acquired abnormalities of uterine anatomy. * 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.

Locations (1)

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, China