Using Gushen Antai Pill to improve pregnancy rates in women undergoing IVF

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.