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NCT Number: NCT07737847

Clinical Study on ShouTai Pills for Improving Reduced Ovarian Reserve

Grounded in the 'disease-syndrome combination' paradigm, this study endeavors to address the pivotal scientific issues pertaining to the clinical precision of Traditional Chinese Medicine (TCM) in managing Diminished Ovarian Reserve (DOR) classified as the Kidney Essence Deficiency type, through the application of systems biology technologies, including metabolomics.

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Key information

Conditions

Diminished Ovarian Reserve (DOR)

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100732, China

Location contact

mai li

CONTACT

[email protected]

+86 01069155707

zhengyi sun, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The inclusion criteria are as follows: ① meeting the above-mentioned integrated Chinese and Western medicine diagnostic criteria for DOR
  • ② no use of estrogen-containing medications within the past 1 month
  • ③ patients scheduled to undergo IVF-ET
  • ④ provision of signed informed consent, voluntary participation, and good compliance.

Exclusion criteria

  • The exclusion criteria are as follows: ① patients with polycystic ovary syndrome (PCOS) or stage III/IV endometriosis
  • ② uterine conditions including untreated submucous myomas, intramural myomas >4 cm in diameter, intrauterine adhesions, uterine septum, or other uterine anomalies
  • ③ couples undergoing preimplantation genetic diagnosis (PGD) for genetic reasons
  • ④ body mass index (BMI) ≥28 kg/m²
  • ⑤ history of prior pelvic radiotherapy or cytotoxic chemotherapy
  • ⑥ significant systemic diseases, such as uncontrolled hypertension, diabetes mellitus, thyroid dysfunction, hepatic or renal insufficiency, cardiac disorders, or autoimmune diseases
  • ⑦ use of medications that may interfere with this study within the past 1 month, including but not limited to estrogens, hepatic enzyme modulators, and agents that may affect the endocrine system (hormonal drugs)
  • ⑧ known allergy to any components of the study medication
  • and ⑨ participation in another drug trial within the past 3 months. -

Treatment and study plan

Shoutai Pill

Drug

The experimental group took Shoutai Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months

Placebo

Drug

The experimental group took placebo Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months

Primary outcomes

  1. Number of MII oocyte

    Time frame: After 3 months of medication, ovulation induction was performed, followed by oocyte retrieval upon completion of the induction cycle. The number of mature oocytes was recorded on the day of retrieval.

    On the day of oocyte retrieval, the number of mature oocytes was observed under a microscope. Mature oocytes are defined as oocytes containing the first polar body.

Secondary outcomes

  1. FSH

    Time frame: Basline， and after 3 months of treatment

    Follicle-Stimulating Hormone

  2. AMH

    Time frame: Basline， and after 3 months of treatment

    Anti-Müllerian Hormone

  3. number of oocytes retrieved

    Time frame: After 3 months of medication, ovulation induction was performed, followed by oocyte retrieval upon completion of the induction cycle. The number of mature oocytes was recorded on the day of retrieval.

    Direct visualization under microscopy

  4. AFC

    Time frame: Basline， and after 3 months of treatment

    antral follicle count

  5. blastocyst formation rate

    Time frame: After 3 months of medication, ovulation induction and oocyte retrieval for fertilization are performed, recorded as Day 0. Blastocysts form on days 5/6 post-fertilization; thus, the blastocyst formation rate is assessed on Day 6

    Number of blastocysts / (number of cleavage-stage embryos - number of transferred embryos

  6. proportion of good-quality embryos

    Time frame: After 3 months of medication, ovulation induction and oocyte retrieval for fertilization are performed, recorded as Day 0. Cleavage embryos form on day3 post-fertilization; thus, the rate is assessed on Day 3

    Number of top-quality embryos / number of cleavage-stage embryos

Study contacts

Contact information is provided by the study sponsor or research team.

xue wang, MD

CONTACT

[email protected]

+86 010 69158335

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Beijing Municipal Health Commission

Registry information

Official study title

A Study on Biological Subtyping of Reduced Ovarian Reserve With Kidney Essence Deficiency Syndrome Based on Follicular Fluid Metabolomics and Efficacy Prediction of ShouTai Pills

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 30, 2026
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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