Diminished Ovarian Reserve (DOR)NCT07737847
Clinical Study on ShouTai Pills for Improving Reduced Ovarian Reserve
A study testing Shoutai Pill in people with Diminished Ovarian Reserve (DOR), run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve (DOR)
- What is being tested?
- Shoutai Pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2026to 31 Dec 2028
- Phase
- Interventional
- 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 20 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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. -
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
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100732
mai li, +86 01069155707, pumchkyc@126.com
zhengyi sun, MD
About this study
Official 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
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.
- Conditions
- Diminished Ovarian Reserve (DOR)
- Being tested
- Shoutai Pill, Placebo
- Keywords
- shoutai pill, oocyte, Diminished Ovarian Reserve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shoutai PillDrug
The experimental group took Shoutai Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months
PlaceboDrug
The experimental group took placebo Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months
| Study group | Role | What they receive |
|---|---|---|
| Shoutai Pill | Experimental | The experimental group took Shoutai Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months Receives: Drug: Shoutai Pill |
| Control group | Placebo comparator | The experimental group took Placebo Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of MII oocyte
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.
Measured: 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.
Secondary outcomes (6)
FSH
Follicle-Stimulating Hormone
Measured: Basline， and after 3 months of treatment
AMH
Anti-Müllerian Hormone
Measured: Basline， and after 3 months of treatment
number of oocytes retrieved
Direct visualization under microscopy
Measured: 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.
AFC
antral follicle count
Measured: Basline， and after 3 months of treatment
blastocyst formation rate
Number of blastocysts / (number of cleavage-stage embryos - number of transferred embryos
Measured: 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
proportion of good-quality embryos
Number of top-quality embryos / number of cleavage-stage embryos
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diminished Ovarian Reserve (DOR)Studies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Municipal Health Commission
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737847
- Sponsor's protocol ID
- I-26PJ0867
- Other IDs
- 首发 2026-2-4019
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07737847
- Acronym / sponsor ID
- I-26PJ0867
- Conditions
- Diminished Ovarian Reserve (DOR)
- Keywords
- shoutai pill, oocyte, Diminished Ovarian Reserve
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Beijing Municipal Health Commission
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 30 Jul 2026 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Shoutai Pill | Experimental | Drug: Shoutai PillThe experimental group took Shoutai Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months |
| Control group | Placebo comparator | Drug: PlaceboThe experimental group took Placebo Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Shoutai PillThe experimental group took Shoutai Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months | Drug | Shoutai Pill |
| PlaceboThe experimental group took placebo Pills, 20 pills each time, twice daily, taken with water, continuously for 3 months | Drug | Control group |
Primary outcome
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.
6 secondary outcomes
FSH
Time frame: Basline， and after 3 months of treatment
AMH
Time frame: Basline， and after 3 months of treatment
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.
AFC
Time frame: Basline， and after 3 months of treatment
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
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
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 30 Jul 2026.
- Individual participant dataSharing planned: Yes. only IPD used in the results publication
Related trials for Diminished Ovarian Reserve (DOR)
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Study of G-CSF for DOR in Patients Undergoing IVF
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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 study testing Shoutai Pill in people with Diminished Ovarian Reserve (DOR), run by Peking Union Medical College Hospital 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 9 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: opening soon, as of the sponsor's last update on 30 Jul 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.
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 xue wang, MD (+86 010 69158335, wangxue2098@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jul 2026.