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
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 42
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
RECRUITING
Jinan
Contact Information
Primary
Zhen-Gao Sun, M.D.
sunzhengao77@126.com
+86-13708938621
Backup
Jing-Yan Song, M.D.
hanlingjuzei91@126.com
+86-1876580013
Time Frame
Start Date: 2021-06-15
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 800
Treatments
Experimental: GSATP group
Gushen Antai Pill (GSATP, 6g\* 9 bags, Beijing boran Pharmaceutical Inc.) was required to be taken orally, 6g three times daily combined with vaginal progesterone (90 mg/day Crinone, Merck) from the day of embryo transfer until 10th gestational week.
Placebo_comparator: Placebo group
Placebo pill is made up of a certain amount of starch and glucose, and is shaped like GSATP according to the National Drug Standards of the State Food and Drug Administration of China. Placebo pill was required to be taken orally, 6g three times daily combined with vaginal progesterone (90 mg/day Crinone, Merck) from the day of embryo transfer until 10th gestational week.
Related Therapeutic Areas
Sponsors
Leads: Shandong University of Traditional Chinese Medicine