AzTrials
AzTrials

Diminished Ovarian Reserve (DOR)Phase 3NCT07376824

Clinical and Metabolomics Studies on the Improvement of Ovarian Reserve by Acupoint Photodynamic Therapy and Traditional Chinese Medicine Treatment

A Phase 3 study testing Traditional Chinese Medicine and Photodynamic therapy (PDT) in people with Diminished Ovarian Reserve (DOR), run by Peking Union Medical College Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Diminished Ovarian Reserve (DOR) refers to a reduction in the number of recruitable follicles in the ovaries and/or a decline in oocyte quality. Current research on its etiology and treatment remains unsatisfactory. Read more about this study

Who is it for?
Ages 25 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Diminished Ovarian Reserve (DOR)
What is being tested?
Traditional Chinese Medicine and Photodynamic therapy (PDT)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
90 participants
Where
1 siteChina
Study dates
20 Dec 2024to 31 Dec 2026
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 25 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Female patients aged 25 to 40 years
  • 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) ③ Meet the diagnostic criteria for kidney deficiency syndrome in traditional Chinese medicine ④ Voluntarily participate in this study and provide written informed consent.

Who cannot join

  • Organic lesions such as ovarian tumors, pituitary adenomas, endometrial tuberculosis, intrauterine adhesions or endometrial damage after abortion, as well as polycystic ovary syndrome, hyperprolactinemia, congenital adrenal hyperplasia, Cushing's syndrome, and thyroid dysfunction
  • Female infertility patients who have been treated with sex hormones in the past 3 months ③ Serious or unstable physical diseases, including liver, kidney, gastrointestinal, cardiovascular, respiratory, endocrine, neurological, immune or hematological, neurological and psychiatric systems,
  • History of substance (alcohol or drug) abuse or dependence within the past 3 months; heavy smokers (defined as those who smoke 20 or more cigarettes per day)
  • Previous allergy to the investigational drug or photosensitivity, or individuals with contraindications to Dingkun Dan ⑥ Have participated in another clinical trial of a investigational drug within the month prior to inclusion in this study (first interview) ⑦ Other conditions that, in the judgment of the investigator, may reduce the likelihood of enrollment or complicate the enrollment process, such as frequent job changes or other circumstances prone to loss to follow-up.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yingying Guo, Doctor contact

86+010-69158331

guoyy28@gmail.com

China1 site, 1 recruiting

  • Peking union medical college hospital

    Beijing, Beijing Municipality, 100730

    Yingying Guo, Doctor, 86+010-69158331, guoyy28@gmail.com

    Aijun Sun, Professor

    Recruiting

Other trials in China

About this study

Diminished Ovarian Reserve (DOR) refers to a reduction in the number of recruitable follicles in the ovaries and/or a decline in oocyte quality. Current research on its etiology and treatment remains unsatisfactory. This study will be conducted as a single-center, prospective, parallel, randomized, controlled clinical trial in DOR patients. Eligible subjects will be randomly assigned to three groups: LLLT (acupoint photodynamic therapy) + placebo (Dingkun Dan Simulant), LLLT (acupoint photodynamic therapy) + Chinese medicine (Dingkun Dan), and Chinese medicine (Dingkun Dan) alone. Clinical data and serum metabolomics will be assessed at baseline and after the 3-month treatment.

Read the detailed description

Ovarian reserve can reflect a woman's fertility and the outcomes of assisted reproductive technology. If not treated promptly, it may progress to Premature Ovarian Failure (POF) within 1 to 6 years, severely affecting a woman's physical and mental health. Studies have found that the incidence of DOR in the female population is approximately 10%, while the prevalence of DOR among infertile women is about 24%, showing an increasing trend year by year and affecting younger age groups. Extensive studies have confirmed that traditional Chinese medicine, as well as integrated traditional Chinese and Western medicine treatments, have certain therapeutic effects on DOR in clinical practice. Early intervention for DOR can improve ovarian reserve function and increase the pregnancy rate. This study will be conducted as a prospective, randomized, controlled clinical trial. Eligible subjects will be randomly assigned to three groups: Combination Therapy Group, Photodynamic Therapy Group, Chinese Medicine Group. After three months of treatment, the study will conduct clinical and metabolomics-based research on DOR patients to: (1) Clarify the role and efficacy of acupoint photodynamic therapy, both alone and in combination with Chinese medicine, in improving or enhancing the effects of traditional Chinese medicine on ovarian reserve function. (2) Explore new metabolic biomarkers for the diagnosis and efficacy evaluation of ovarian reserve function. (3) Identify the distinct metabolic pathways through which acupoint photodynamic therapy and Chinese medicine improve ovarian reserve function. (4) Establish an integrated biomarker index system for the diagnosis and treatment evaluation of DOR using acupoint photodynamic therapy and traditional Chinese medicine, and elucidate the mechanisms of action and pharmacodynamic material basis for improving ovarian reserve function.

Being tested
Traditional Chinese Medicine, Photodynamic therapy (PDT), Placebo
Keywords
diminished ovarian reserve, Integrated Traditional Chinese and Western Clinical Medicine, Randomized controlled trial, Photodynamic Therapy, metabolomics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Traditional Chinese MedicineDrug

    Dingkun Dan 7g, twice daily (bid) for 21 days per month, administered orally for 3 treatment cycles.

  • Photodynamic therapy (PDT)Device

    LLLT: The acupoint phototherapy device, with a peak wavelength of 630nm ± 20nm and an output optical power of 1-2.5mW, was used. Treatment commenced after the end of the menstrual period, once daily for 20 minutes per session, for 5 days (constituting one treatment cycle). After a 2-day interval, the next treatment cycle began, continuing until the onset of the next menstruation.

  • PlaceboDrug

    Placebo: Simulated Dingkun Dan preparation, 7g, twice daily (bid) for 21 days per month, administered orally for 3 treatment cycles.

Study groups in NCT07376824
Study groupRoleWhat they receive
Combination Therapy GroupExperimentalLLLT (acupoint photodynamic therapy) + Dingkun Dan Group
Receives: Drug: Traditional Chinese Medicine; Device: Photodynamic therapy (PDT)
Photodynamic Therapy GroupPlacebo comparatorLLLT (acupoint photodynamic therapy) + placebo (Dingkun Dan Simulant)
Receives: Device: Photodynamic therapy (PDT); Drug: Placebo
Chinese Medicine GroupActive comparatorDingkun Dan Monotherapy Group
Receives: Drug: Traditional Chinese Medicine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in serum anti-Müllerian hormone (AMH) concentration

    Change in serum anti-Müllerian hormone (AMH) concentration, measured as the difference from baseline.

    Measured: At 3 months after treatment initiation.

  2. Change in serum follicle-stimulating hormone (FSH) concentration

    Change in serum follicle-stimulating hormone (FSH) concentration, measured as the difference from baseline.

    Measured: At 3 months after treatment initiation.

  3. Change in antral follicle count (AFC)

    Change in antral follicle count (AFC), measured as the difference from baseline.

    Measured: At 3 months after treatment initiation.

Secondary outcomes (4)

  1. Change in serum concentrations of biochemical markers

    Changes in serum concentrations of prostaglandin E2 (PGE2), prostaglandin F2α (PGF2α), endothelin (ET), nitric oxide (NO), β-endorphin, and oxytocin (OT), measured as the change from baseline.

    Measured: At 3 months after treatment initiation.

  2. Change in menstrual blood loss assessed by the Pictorial Blood Loss Assessment Chart (PBAC)

    Change in menstrual blood loss assessed using the Pictorial Blood Loss Assessment Chart (PBAC), a validated semi-quantitative scale ranging from 0 to >500, with higher scores indicating greater menstrual blood loss, measured as the change from baseline.

    Measured: At 3 months after treatment initiation.

  3. Change in traditional Chinese medicine (TCM) syndrome score for menstrual disorders

    Change in traditional Chinese medicine (TCM) syndrome score for menstrual disorders assessed using a quantitative TCM syndrome differentiation scale for menstrual disorders, consisting of major and minor symptom items. The total score ranges from 0 to 42, with higher scores indicating greater symptom severity, measured as the change from baseline.

    Measured: At 3 months after treatment initiation.

  4. Change in health-related quality of life

    Change in health-related quality of life assessed using the 36-Item Short Form Health Survey (SF-36), a validated questionnaire with domain scores ranging from 0 to 100, where higher scores indicate better health-related quality of life, measured as the change from baseline.

    Measured: At 3 months after treatment initiation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2026
  2. Study start20 Dec 2024
  3. Primary completion1 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07376824
Sponsor's protocol ID
SF2024
Status last verified
Nov 2025
First submitted
2 Dec 2025
Last updated
29 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Traditional Chinese Medicine and Photodynamic therapy (PDT) 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 2 inclusion and 4 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 29 Jan 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 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?

Change in serum anti-Müllerian hormone (AMH) concentration (time frame: At 3 months after treatment initiation.). The study lists 3 primary outcomes in all. 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 NCT07376824.

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 29 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in