Using Gushen Antai Pill to improve pregnancy rates in women undergoing IVF
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
This study is testing if taking Gushen Antai Pill can help women with normal ovarian reserve have a better chance of getting pregnant during IVF.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 21 Years to 42 Years |
| Sex | Female |
| Sponsor | Shandong University of Traditional Chinese Medicine Academic / other |
| Drugs / interventions | radiation, prednisone |
| Locations | 1 site (Jinan, Shandong) |
| Trial ID | NCT04872660 on ClinicalTrials.gov |
What this trial studies
This study investigates the efficacy and safety of Gushen Antai Pill as a supplement for luteal phase support in women with normal ovarian reserve undergoing in vitro fertilization with embryo transfer. The trial aims to determine if this traditional Chinese medicine can enhance the ongoing pregnancy rate by improving endometrial receptivity. Participants will be randomly assigned to receive either the Gushen Antai Pill or a placebo during their IVF cycle. The study focuses on women with specific eligibility criteria to ensure a controlled environment for assessing the treatment's effectiveness.
Who should consider this trial
Good fit: Ideal candidates are women with normal ovarian reserve who are undergoing their first IVF or ICSI treatment.
Not a fit: Patients with a history of multiple IVF failures or certain reproductive health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve pregnancy rates for women undergoing IVF.
How similar studies have performed: Previous studies have shown positive effects of traditional Chinese medicine in supporting pregnancy, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Jinan, Shandong
- The Affiliated Hospital of Shandong University of Traditional Chinese Medicine — Jinan, Shandong, China (Recruiting)
Study contacts
- Study coordinator: Zhen-Gao Sun, M.D.
- Email: sunzhengao77@126.com
- Phone: +86-13708938621
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.