Diminished Ovarian Reserve (DOR)Phase 3NCT07296614
Clinical Evaluation of Integrated Chinese-Western Medicine for Infertility With DOR Patients in Women Achieving Natural Pregnancy
A Phase 3 study testing Western Medicine and Traditional Chinese Medicine in people with Diminished Ovarian Reserve (DOR) and Infertility, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study aims to evaluate the superiority of an integrated traditional Chinese and Western medicine regimen ("Xiehe DOR Bushen Tongzhi Formula" + ovulation induction therapy with ovulation monitoring and timed intercourse) compared to standard treatment alone (placebo + ovulation induction therapy with ovulation… Read more about this study
- Who is it for?
- Ages 22 to 39 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve (DOR), Infertility
- What is being tested?
- Western Medicine and Traditional Chinese Medicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2025to 30 Jul 2028
- Phase
- Phase 3
- 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 22 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 22 to 39 years (inclusive).
- Meet the diagnostic criteria for diminished ovarian reserve (requiring at least two of the following: Basal FSH 10-25 IU/L; AMH < 1.1 ng/mL; AFC < 7) and infertility(defined as the failure to achieve pregnancy after 12 months of regular unprotected sexual intercourse).
- Meet the diagnostic criteria for kidney deficiency syndrome in traditional Chinese medicine
- Voluntarily participate in this study and provide written informed consent.
Who cannot join
- Patients with premature ovarian insufficiency or premature ovarian failure (basal FSH >25 IU/L), organic pathologies such as ovarian tumors, endometrial tuberculosis, intrauterine adhesions, or endometrial injuries, as well as those with congenital adrenal hyperplasia or Cushing's syndrome;
- Infertility caused by organic lesions of the fallopian tubes, uterus, cervix, etc.
- Infertility due to male factors (based on semen analysis reports, meeting the diagnostic criteria for oligoasthenoteratozoospermia according to the WHO 5th edition standards).
- DOR caused by iatrogenic factors (such as pelvic surgery, radiotherapy/chemotherapy, uterine artery embolization, etc.).
- Patients with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems, or psychiatric disorders.
- Individuals with known allergies to the investigational drug or its components.
- Use of hormonal medications (e.g., estrogen, contraceptive drugs) within one month prior to enrollment, or use of kidney-tonifying Chinese herbal medicines or proprietary Chinese medicinal products within one month prior to enrollment.
- Patients currently participating in or planning to participate in other clinical trials.
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, 100730
About this study
Official title: Integrative Chinese and Western Medicine for Diminished Ovarian Reserve-Associated Infertility in Natural Conception Population
This study aims to evaluate the superiority of an integrated traditional Chinese and Western medicine regimen ("Xiehe DOR Bushen Tongzhi Formula" + ovulation induction therapy with ovulation monitoring and timed intercourse) compared to standard treatment alone (placebo + ovulation induction therapy with ovulation monitoring and timed intercourse) in improving the natural cumulative clinical pregnancy rate in infertile patients with kidney deficiency-type diminished ovarian reserve (DOR).
- Conditions
- Diminished Ovarian Reserve (DOR), Infertility
- Being tested
- Western Medicine, Traditional Chinese Medicine, Placebo
- Keywords
- Diminished ovarian reserve (DOR), Infertility, Integrated Traditional Chinese and Western Clinical Medicine, Randomized controlled trial
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Western MedicineDrug
Letrozole is administered orally at 2.5 mg once daily from Day 2 to Day 5 of the menstrual cycle (5 consecutive days).
Traditional Chinese MedicineDrug
"Xiehe DOR Kidney-Tonifying Universal Formula" is a traditional Chinese medicine (TCM) granule formulation prepared in-hospital. It is taken by dissolving one sachet in hot water, three times daily.
PlaceboDrug
The appearance and packaging of the placebo are exactly the same as those of "Xiehe DOR Kidney-Tonifying Universal Formula". It is also taken by dissolving one sachet in hot water, three times daily.
| Study group | Role | What they receive |
|---|---|---|
| Western medicine group | Placebo comparator | Take the placebo granules orally for three months, followed by three cycles of letrozole while continuing the placebo. Receives: Drug: Western Medicine; Drug: Placebo |
| Integrated traditional Chinese and Western medicine | Experimental | Take the "Xiehe DOR Kidney-Tonifying Universal Formula" orally for three months; thereafter, continue the Chinese herbal formula while combining it with three cycles of letrozole. Receives: Drug: Western Medicine; Drug: Traditional Chinese Medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative clinical pregnancy rate
The rate of intrauterine pregnancy confirmed by transvaginal ultrasound
Measured: Assessed at study completion, approximately 6 months after enrollment.
Secondary outcomes (1)
Indicators related to ovarian reserve function
sex hormone levels(AMH, FSH), antral follicle count(AFC)
Measured: Baseline, 3-months, 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start25 Dec 2025 (estimated)
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dongfang Hospital Beijing University of Chinese Medicine, Beijing University of Chinese Medicine, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Shandong University, Xiamen University, Beijing Obstetrics and Gynecology Hospital, Xiyuan Hospital of China Academy of Chinese Medical Sciences, The Third Affiliated Hospital of Beijing University of Chinese Medicine, Hunan Provincial Maternal and Child Health Care Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Institute of Basic Medical Sciences CAMS, First Affiliated Hospital of Heilongjiang Chinese Medicine University, Shunde Women and Children's Hospital (Maternity and Child Healthcare Hospital of Shunde Foshan), The First Affiliated Hospital of Zhengzhou University, Shenyang Maternal and Child Health Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296614
- Sponsor's protocol ID
- K9220
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Chinese and Western Medicine for Diminished Ovarian Reserve-Associated Infertility in Natural Conception Population
- ClinicalTrials.gov ID
- NCT07296614
- Acronym / sponsor ID
- K9220
- Conditions
- Diminished Ovarian Reserve (DOR), Infertility
- Keywords
- Diminished ovarian reserve (DOR), Infertility, Integrated Traditional Chinese and Western Clinical Medicine, Randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Dongfang Hospital Beijing University of Chinese Medicine, Beijing University of Chinese Medicine, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Shandong University, Xiamen University, Beijing Obstetrics and Gynecology Hospital, Xiyuan Hospital of China Academy of Chinese Medical Sciences, The Third Affiliated Hospital of Beijing University of Chinese Medicine, Hunan Provincial Maternal and Child Health Care Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Institute of Basic Medical Sciences CAMS, First Affiliated Hospital of Heilongjiang Chinese Medicine University, Shunde Women and Children's Hospital (Maternity and Child Healthcare Hospital of Shunde Foshan), The First Affiliated Hospital of Zhengzhou University, Shenyang Maternal and Child Health Hospital
- Study start
- 25 Dec 2025 (estimated)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 22 Dec 2025 (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.
This study aims to evaluate the superiority of an integrated traditional Chinese and Western medicine regimen ("Xiehe DOR Bushen Tongzhi Formula" + ovulation induction therapy with ovulation monitoring and timed intercourse) compared to standard treatment alone (placebo + ovulation induction therapy with ovulation monitoring and timed intercourse) in improving the natural cumulative clinical pregnancy rate in infertile patients with kidney deficiency-type diminished ovarian reserve (DOR).
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 |
|---|---|---|
| Western medicine group | Placebo comparator | Drug: Western Medicine, Drug: PlaceboTake the placebo granules orally for three months, followed by three cycles of letrozole while continuing the placebo. |
| Integrated traditional Chinese and Western medicine | Experimental | Drug: Western Medicine, Drug: Traditional Chinese MedicineTake the "Xiehe DOR Kidney-Tonifying Universal Formula" orally for three months; thereafter, continue the Chinese herbal formula while combining it with three cycles of letrozole. |
Who may qualify
- Ages
- 22 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female patients aged 22 to 39 years (inclusive).
- Meet the diagnostic criteria for diminished ovarian reserve (requiring at least two of the following: Basal FSH 10-25 IU/L; AMH < 1.1 ng/mL; AFC < 7) and infertility(defined as the failure to achieve pregnancy after 12 months of regular unprotected sexual intercourse).
- Meet the diagnostic criteria for kidney deficiency syndrome in traditional Chinese medicine
- Voluntarily participate in this study and provide written informed consent.
Key exclusion criteria (8 listed)
- Patients with premature ovarian insufficiency or premature ovarian failure (basal FSH >25 IU/L), organic pathologies such as ovarian tumors, endometrial tuberculosis, intrauterine adhesions, or endometrial injuries, as well as those with congenital adrenal hyperplasia or Cushing's syndrome;
- Infertility caused by organic lesions of the fallopian tubes, uterus, cervix, etc.
- Infertility due to male factors (based on semen analysis reports, meeting the diagnostic criteria for oligoasthenoteratozoospermia according to the WHO 5th edition standards).
- DOR caused by iatrogenic factors (such as pelvic surgery, radiotherapy/chemotherapy, uterine artery embolization, etc.).
- Patients with severe primary diseases of the cardiovascular, cerebrovascular, hepatic, renal, or hematopoietic systems, or psychiatric disorders.
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 |
|---|---|---|
| Western MedicineLetrozole is administered orally at 2.5 mg once daily from Day 2 to Day 5 of the menstrual cycle (5 consecutive days). | Drug | Integrated traditional Chinese and Western medicine, Western medicine group |
| Traditional Chinese Medicine"Xiehe DOR Kidney-Tonifying Universal Formula" is a traditional Chinese medicine (TCM) granule formulation prepared in-hospital. It is taken by dissolving one sachet in hot water, three times daily. | Drug | Integrated traditional Chinese and Western medicine |
| PlaceboThe appearance and packaging of the placebo are exactly the same as those of "Xiehe DOR Kidney-Tonifying Universal Formula". It is also taken by dissolving one sachet in hot water, three times daily. | Drug | Western medicine group |
Primary outcome
Cumulative clinical pregnancy rate
Time frame: Assessed at study completion, approximately 6 months after enrollment.
The rate of intrauterine pregnancy confirmed by transvaginal ultrasound
1 secondary outcome
Indicators related to ovarian reserve function
Time frame: Baseline, 3-months, 6-months
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 22 Dec 2025.
- 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 3 study testing Western Medicine and Traditional Chinese Medicine in people with Diminished Ovarian Reserve (DOR) and Infertility, 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 8 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 22 Dec 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Yingying Guo, Doctor (86+010-69158331, guoyy28@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative clinical pregnancy rate (time frame: Assessed at study completion, approximately 6 months after enrollment.). 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 22 Dec 2025.