Infertility, FemalePhase 4GSATP-FreETNCT04872660
Efficacy and Safety of Gushen Antai Pill on Ongoing Pregnancy Rate in Women With Normal Ovarian Reserve Undergoing IVF-ET
A Phase 4 study testing Gushen Antai Pill in people with Infertility, Female, run by Shandong University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 42 years, women only
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Gushen Antai Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2021to 30 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, 250014
Zhen-Gao Sun, PhD, +8613708938621, sunzhengao77@126.com
About this study
Official title: 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
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.
Read the detailed description
Infertility is a growing reproductive health problem, and it is estimated that approximately 15% of couples of reproductive ages are affected. The invention and popularity of IVF-ET technology, although improving sperm egg encounter and fertilization barriers and implanting early embryos from the uterine cavity in vitro, still do not solve the problem of the uterine implantation environment or endometrial receptivity, and the pregnancy rate needs to be further improved. However, traditional Chinese medicine (TCM) has an original theoretical understanding and exact efficacy for gynecological diseases, therefore, it is necessary to supplement TCM interventions with endometrial receptivity as described above.
TCM is a kind of traditional treatment method with thousands of years history in China, and some previous studies have shown its unique experience in assisting pregnancy and reduce vaginal bleeding in early pregnancy . Similar to the notion of "hypothalamus- pituitary-ovary axis" that is established by Western medicine, TCM also has deeply studied the reproductive regulation of kidney and proposed the concept of "kidney-Tian Gui-Chong Ren-uterine axis." According to TCM, "Kidney Governs Reproduction," and female infertility is closely related to kidney deficiency, and the main therapeutic principle of it involves tonification of the kidney.
GSATP is widely used as an adjunctive therapy in women with threatened abortion in China and the clinical effects reflected by the patients remained satisfactory. The function of GSATP is nourishing yin and tonifying the kidney, strengthening Chong and prevent miscarriage. GSATP is used in the early threatened abortion, which belongs to the kidney yin deficiency syndrome of traditional Chinese medicine. GSATP is made up of Dodder, uncaria, Scutellaria, Atractylodes macrocephala, white peony, rehmannia, Polygonum multiflorum, Dipsacus, Cistanche deserticola, mulberry parasitism. The main components of GSATP include baicalin, Atractylodes macrocephala polysaccharide, flavonoids from Cuscuta chinensis, rhynchophylline, polysaccharides, Cistanche polysaccharides, stilbene glycosides and anthraquinone glycosides and triterpenoid saponins, etc. Modern pharmacological studies have found that these ingredients can improve vascular function, regulate immune activity, inhibit uterine contraction and improve ovarian endocrine function, so GSATP may play a role in promoting embryo implantation and preventing pregnancy. However, to improve the success rate of embryo implantation is a complex process and has not been fully studied. Therefore, in treating complex diseases, multi-targeted therapy such as TCM might have unique advantages over western medicine treatment alone. Although GSATP is associated with very good response in patients, lack of high-quality evidence-based medicine has restricted its promotion. The combination of evidence-based medicine, modern medicine and traditional Chinese medicine is a huge field that involves continuous attention and efforts.
GSATP dramatically increased the ongoing pregnancy rate and decreased the prevalence of vaginal bleeding in patients undergoing frozen thawed embryo transfer in our previous study. Recently, it was demonstrated that luteal support combined with GSATP could dramatically increase embryo implantation and clinical pregnancy rates, as well as early pregnancy loss rates, in IVF-ET fresh embryo transfer cycles. However, the study's methodological deficiencies prevented it from reaching a definitive conclusion about GSATP's treatment effect. This was mostly attributed to the unspecified randomization process, the absence of distribution concealment and blinding, no placebo control, and vague inclusion and exclusion criteria. As a result, a well-designed randomized clinical trial is essential to estimate the efficiency and safety of GSATP in optimizing reproductive outcomes in women with normal ovarian reserve during fresh embryo transfer cycles.
- Conditions
- Infertility, Female
- Being tested
- Gushen Antai Pill, Placebo pill
- Keywords
- Traditional Chinese Medicine, In vitro fertilization-embryo transfer, Gushen Antai Pill, Normal ovarian reserve, Ongoing pregnancy rate
- Medical subject headings
- Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate
A fetal heartbeat detected by transvaginal ultrasonography over 12 gestational weeks. [Detected via ultrasound]
Measured: 10 weeks after the day of embryo transfer
Secondary outcomes (9)
Positive pregnancy rate
Serum β-hCG level ≥ 10mIU/mL, 14 days after embryo transfer. [Detected via ELISA]
Measured: 2 weeks after the day of embryo transfer
Embryo implantation rate
The number of intrauterine gestational sacs observed divided by the number of embryos transferred. [Detected via ultrasound]
Measured: 3 weeks after the day of embryo transfer
Clinical pregnancy rate
An intrauterine gestational sac with fetal heartbeat detected by transvaginal ultrasonography. [Detected via ultrasound]
Measured: 4 weeks after the day of embryo transfer
Ectopic pregnancy rate
A pregnancy in which implantation takes place outside the uterine cavity. [Detected via ultrasound]
Measured: 4 weeks after the day of embryo transfer
Pregnancy loss rate
Clinically recognized spontaneous loss of pregnancy before the completion of twelve gestational weeks. [Detected via ultrasound]
Measured: 10 weeks after the day of embryo transfer
Multiple pregnancy rate
There were two or more simultaneous fetuses in the uterine cavity. [Detected via ultrasound]
Measured: 10 weeks after the day of embryo transfer
The prevalence of pregnancy constipation
Functional constipation as the presence of at least two out of six symptoms: straining, lumpy or hard stools, a sensation of incomplete evacuation, a sensation of anorectal obstruction/blockage, manual manoeuvres to facilitate defecation and fewer than three spontaneous bowel movements per week. Symptoms must be present at 25% of the defecations and last at least one months. [Evaluated via questionnaire]
Measured: 10 weeks after the day of embryo transfer
The prevalence of threatened abortion
Abdominal pain and vaginal bleeding happened in the first trimester, but the intrauterine fetus still survived. [Detected via ultrasound]
Measured: 10 weeks after the day of embryo transfer
Live birth rate
Live birth, defined as the birth of at least one child with breath and heartbeat.
Measured: Beyond 24 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start15 Jun 2021
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing-Yan Song, Shandong University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872660
- Sponsor's protocol ID
- SDUTCMSZG770214
- Acronym
- GSATP-FreET
- Status last verified
- Mar 2026
- First submitted
- 29 Apr 2021
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25801630Ried 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.
PubMed 25637159Smith 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.
PubMed 26866600Shen 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
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.
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.
Ma B. Research progress on hypotensive effect and mechanism of Uncariarhynchophylla [in Chinese]. China Med Guide. 2011; 8(7):12-4.
Wang P. Modern pharmacological research and clinical application of Rehmannia glutinosa [in Chinese]. Modern Distance Educ Trad Chin Med China. 2008; 6(8):986
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.
PubMed 33071986Lu 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.
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.
PubMed 41322369Xu 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.
PubMed 40082945
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04872660
- Acronym / sponsor ID
- GSATP-FreET / SDUTCMSZG770214
- Conditions
- Infertility, Female
- Keywords
- Traditional Chinese Medicine, In vitro fertilization-embryo transfer, Gushen Antai Pill, Normal ovarian reserve, Ongoing pregnancy rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Shandong University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Infertility is a growing reproductive health problem, and it is estimated that approximately 15% of couples of reproductive ages are affected. The invention and popularity of IVF-ET technology, although improving sperm egg encounter and fertilization barriers and implanting early embryos from the uterine cavity in vitro, still do not solve the problem of the uterine implantation environment or endometrial receptivity, and the pregnancy rate needs to be further improved. However, traditional Chinese medicine (TCM) has an original theoretical understanding and exact efficacy for gynecological diseases, therefore, it is necessary to supplement TCM interventions with endometrial receptivity as described above.
TCM is a kind of traditional treatment method with thousands of years history in China, and some previous studies have shown its unique experience in assisting pregnancy and reduce vaginal bleeding in early pregnancy . Similar to the notion of "hypothalamus- pituitary-ovary axis" that is established by Western medicine, TCM also has deeply studied the reproductive regulation of kidney and proposed the concept of "kidney-Tian Gui-Chong Ren-uterine axis." According to TCM, "Kidney Governs Reproduction," and female infertility is closely related to kidney deficiency, and the main therapeutic principle of it involves tonification of the kidney.
GSATP is widely used as an adjunctive therapy in women with threatened abortion in China and the clinical effects reflected by the patients remained satisfactory. The function of GSATP is nourishing yin and tonifying the kidney, strengthening Chong and prevent miscarriage. GSATP is used in the early threatened abortion, which belongs to the kidney yin deficiency syndrome of traditional Chinese medicine. GSATP is made up of Dodder, uncaria, Scutellaria, Atractylodes macrocephala, white peony, rehmannia, Polygonum multiflorum, Dipsacus, Cistanche deserticola, mulberry parasitism. The main components of GSATP include baicalin, Atractylodes macrocephala polysaccharide, flavonoids from Cuscuta chinensis, rhynchophylline, polysaccharides, Cistanche polysaccharides, stilbene glycosides and anthraquinone glycosides and triterpenoid saponins, etc. Modern pharmacological studies have found that these ingredients can improve vascular function, regulate immune activity, inhibit uterine contraction and improve ovarian endocrine function, so GSATP may play a role in promoting embryo implantation and preventing pregnancy. However, to improve the success rate of embryo implantation is a complex process and has not been fully studied. Therefore, in treating complex diseases, multi-targeted therapy such as TCM might have unique advantages over western medicine treatment alone. Although GSATP is associated with very good response in patients, lack of high-quality evidence-based medicine has restricted its promotion. The combination of evidence-based medicine, modern medicine and traditional Chinese medicine is a huge field that involves continuous attention and efforts.
GSATP dramatically increased the ongoing pregnancy rate and decreased the prevalence of vaginal bleeding in patients undergoing frozen thawed embryo transfer in our previous study. Recently, it was demonstrated that luteal support combined with GSATP could dramatically increase embryo implantation and clinical pregnancy rates, as well as early pregnancy loss rates, in IVF-ET fresh embryo transfer cycles. However, the study's methodological deficiencies prevented it from reaching a definitive conclusion about GSATP's treatment effect. This was mostly attributed to the unspecified randomization process, the absence of distribution concealment and blinding, no placebo control, and vague inclusion and exclusion criteria. As a result, a well-designed randomized clinical trial is essential to estimate the efficiency and safety of GSATP in optimizing reproductive outcomes in women with normal ovarian reserve during fresh embryo transfer cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GSATP group | Experimental | Drug: Gushen Antai PillGushen 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 group | Placebo comparator | Drug: Placebo pillPlacebo 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. |
Who may qualify
- Ages
- 21 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gushen Antai PillThe 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. | Drug | GSATP group |
| Placebo pillThe 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. | Drug | Placebo group |
Primary outcome
Ongoing pregnancy rate
Time frame: 10 weeks after the day of embryo transfer
A fetal heartbeat detected by transvaginal ultrasonography over 12 gestational weeks. [Detected via ultrasound]
9 secondary outcomes
Positive pregnancy rate
Time frame: 2 weeks after the day of embryo transfer
Embryo implantation rate
Time frame: 3 weeks after the day of embryo transfer
Clinical pregnancy rate
Time frame: 4 weeks after the day of embryo transfer
Ectopic pregnancy rate
Time frame: 4 weeks after the day of embryo transfer
Pregnancy loss rate
Time frame: 10 weeks after the day of embryo transfer
Multiple pregnancy rate
Time frame: 10 weeks after the day of embryo transfer
The prevalence of pregnancy constipation
Time frame: 10 weeks after the day of embryo transfer
The prevalence of threatened abortion
Time frame: 10 weeks after the day of embryo transfer
Live birth rate
Time frame: Beyond 24 weeks of gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background: PubMed 25801630Inhorn 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.
- Background: PubMed 25637159Ried 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.
- Background: PubMed 26866600Smith 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.
- BackgroundShen 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
- BackgroundQin 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.
- BackgroundChen 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.
- BackgroundMa B. Research progress on hypotensive effect and mechanism of Uncariarhynchophylla [in Chinese]. China Med Guide. 2011; 8(7):12-4.
- BackgroundWang P. Modern pharmacological research and clinical application of Rehmannia glutinosa [in Chinese]. Modern Distance Educ Trad Chin Med China. 2008; 6(8):986
- Background: PubMed 33071986Cao 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.
- BackgroundLu 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.
- Derived from this study: PubMed 41322369Xu 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.
- Derived from this study: PubMed 40082945Xu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gushen Antai Pill in people with Infertility, Female, run by Shandong University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhen-Gao Sun, M.D. (+86-13708938621, sunzhengao77@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing pregnancy rate (time frame: 10 weeks after the day of embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04872660, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.