Efficacy and Safety of Gushen Antai Pill on Ongoing Pregnancy Rate in Women With Normal Ovarian R… (NCT04872660) | Clinical Trial Compass
RecruitingPhase 4
Efficacy and Safety of Gushen Antai Pill on Ongoing Pregnancy Rate in Women With Normal Ovarian Reserve Undergoing IVF-ET
China800 participantsStarted 2021-06-15
Plain-language 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.
Who can participate
Age range21 Years – 42 Years
SexFEMALE
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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 o…
What they're measuring
1
Ongoing pregnancy rate
Timeframe: 10 weeks after the day of embryo transfer
Trial details
NCT IDNCT04872660
SponsorShandong University of Traditional Chinese Medicine