NCT04872660

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for phase_4

Timeline
7mo left

Started Jun 2021

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jun 2021Dec 2026

First Submitted

Initial submission to the registry

April 29, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2021

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

April 29, 2021

Last Update Submit

March 6, 2026

Conditions

Infertility, Female

Keywords

Traditional Chinese MedicineIn vitro fertilization-embryo transferGushen Antai PillNormal ovarian reserveOngoing pregnancy rate

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate

    A fetal heartbeat detected by transvaginal ultrasonography over 12 gestational weeks. \[Detected via ultrasound\]

    10 weeks after the day of embryo transfer

Secondary Outcomes (9)

  • Positive pregnancy rate

    2 weeks after the day of embryo transfer

  • Embryo implantation rate

    3 weeks after the day of embryo transfer

  • Clinical pregnancy rate

    4 weeks after the day of embryo transfer

  • Ectopic pregnancy rate

    4 weeks after the day of embryo transfer

  • Pregnancy loss rate

    10 weeks after the day of embryo transfer

  • +4 more secondary outcomes

Study Arms (2)

GSATP group

EXPERIMENTAL

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.

Drug: Gushen Antai Pill

Placebo group

PLACEBO COMPARATOR

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.

Drug: Placebo pill

Interventions

Gushen Antai PillDRUG

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.

GSATP group
Placebo pillDRUG

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.

Placebo group

Eligibility Criteria

Age21 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, 250014, China

RECRUITING

Related Publications (12)

  • Inhorn MC, Patrizio P. Infertility around the globe: new thinking on gender, reproductive technologies and global movements in the 21st century. Hum Reprod Update. 2015 Jul-Aug;21(4):411-26. doi: 10.1093/humupd/dmv016. Epub 2015 Mar 22.

    PMID: 25801630BACKGROUND

  • Ried K. Chinese herbal medicine for female infertility: an updated meta-analysis. Complement Ther Med. 2015 Feb;23(1):116-28. doi: 10.1016/j.ctim.2014.12.004. Epub 2015 Jan 3.

    PMID: 25637159BACKGROUND

  • Smith CA, Armour M, Ee C. Complementary Therapies and Medicines and Reproductive Medicine. Semin Reprod Med. 2016 Mar;34(2):67-73. doi: 10.1055/s-0035-1571194. Epub 2016 Feb 11.

    PMID: 26866600BACKGROUND

  • Shen L-H. Observation on the effect of Gushen Antai pill combined withprogesterone on Early Threatened Abortion [in Chinese]. Chin J Maternal Child HealthCare. 2012; 27:4628-9

    BACKGROUND

  • Qin D-N, She B-R, She Y-C. Effects of Flavonoids from Cuscuta chinensis on reproductivefunction of experimental animals and human villi [in Chinese]. Chin J New Drugs Clin Pharmacol. 2000; 11(6):349-51.

    BACKGROUND

  • Chen W-X, Chen S-H, Li W-J, Shu Q, Jiang D-Q. Modern pharmacological study on the sedative effect of baicalein andAtractylodes macrocephala [in Chinese]. J Clin Rational Drug Use. 2012; 5(12B):177-8.

    BACKGROUND

  • Ma B. Research progress on hypotensive effect and mechanism of Uncariarhynchophylla [in Chinese]. China Med Guide. 2011; 8(7):12-4.

    BACKGROUND

  • Wang P. Modern pharmacological research and clinical application of Rehmannia glutinosa [in Chinese]. Modern Distance Educ Trad Chin Med China. 2008; 6(8):986

    BACKGROUND

  • Cao XL, Song JY, Zhang XX, Chen YH, Teng YL, Liu HP, Deng TY, Sun ZG. Effects of a Chinese Patent Medicine Gushen'antai Pills on Ongoing Pregnancy Rate of Hormone Therapy FET Cycles: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Front Endocrinol (Lausanne). 2020 Sep 23;11:581719. doi: 10.3389/fendo.2020.581719. eCollection 2020.

    PMID: 33071986BACKGROUND

  • Lu Y, Long XL. Clinical efficacy of Gushen Antai pill combined with progesterone after in vitro fertilization and embryo transfer [in Chinese]. Maternal and Child Health Care of China. 2017;32(9):1980-2.

    BACKGROUND

  • Xu Y, Hu X, Ai KL, Sun ZG, Song JY. Integrating Chinese Herbal Medicine in IVF: A Protocol for Randomized Controlled Trial of Gushen Antai Pill. Int J Womens Health. 2025 Nov 25;17:4855-4866. doi: 10.2147/IJWH.S554939. eCollection 2025.

    PMID: 41322369DERIVED

  • Xu Y, Hu X, Ai KL, Sun ZG, Song JY. Gushen Antai pill for expected normal ovarian responders undergoing IVF-ET (GSATP-FreET): interim analysis of a randomized controlled trial. Contracept Reprod Med. 2025 Mar 13;10(1):19. doi: 10.1186/s40834-025-00352-9.

    PMID: 40082945DERIVED

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Central Study Contacts

Zhen-Gao Sun, M.D.

CONTACT

+86-13708938621sunzhengao77@126.com

Jing-Yan Song, M.D.

CONTACT

+86-1876580013hanlingjuzei91@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 4, 2021

Study Start

June 15, 2021

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)