Diminished Ovarian Reserve (DOR)Phase 3DORNCT07550998
Yulinzhu for Women With Diminished Ovarian Reserve
A Phase 3 study testing Yulinzhu (a Chinese Medicinal Formulae) in people with Diminished Ovarian Reserve (DOR), run by The University of Hong Kong at 2 sites in Hong Kong.
Trial summary
This is a randomized waiting-list controlled crossover trial carried out to investigate the efficacy of traditional Chinese medicine (TCM) for DOR and its potential beneficial effects on fertility. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Diminished Ovarian Reserve (DOR)
- What is being tested?
- Yulinzhu (a Chinese Medicinal Formulae)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesHong Kong
- Study dates
- 24 Apr 2026to 31 Oct 2027
- Phase
- Phase 3
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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-40, with regular menstruation (cycle from 21 to 35 days) and reduced fertility (infertility, early miscarriage, recurrent pregnancy loss, recurrent implantation failure, etc.) ;
- Tests of ovarian reserve within 6 months:
- AMH < 1.1 ng/ml or (any day in cycle, refer to laboratory standards);
- AFC < 7 follicles or (any day in cycle);
- Received <3 cycles of IVF in public sector;
- Subject has no history of allergy to TCM;
- Subjects agree to receive IVF treatment upon the completion of this research within 12 weeks if they are not pregnant spontaneously; and
- As diagnosed by Chinese Medicine practitioner through four diagnostic methods, suitable to receive Yulinzhu.
Who cannot join
- Previous history of a unilateral or bilateral oophorectomy;
- Recent administration of TCM for DOR within 3 months;
- Diagnosis of pregnancy, premature ovarian failure, residual follicles, cysts or space-occupying lesions in the ovary, pelvic inflammatory disease or polycystic ovary syndrome; and
- Cancer, untreated thyroid dysfunction, severe cardiovascular/cerebrovascular diseases, severe liver/kidney diseases or hematopoietic system diseases.
- Subjects are allowed to withdraw from the trial for one of the following reasons:
- The patient fails to complete treatment due to safety or medical reasons; (2) The patient fails to follow treatment guidelines; (3) The patient is unwilling to continue treatment for any reason.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites, 2 recruiting
- Not yet recruiting
Kwung Wah Hospital
Hong Kong
Man Wai Associate Consultant, +852 3517 1401, hmw562@ha.org.hk
- Recruiting
Queen Marry Hosipital
Hong Kong
Kwai Ching Lecturer, PHD, +852 3917 6462, angelos@hku.hk
About this study
Official title: Yulinzhu for Women With Diminished Ovarian Reserve: a Randomized, Waiting-list Controlled, Crossover Trial
This is a randomized waiting-list controlled crossover trial carried out to investigate the efficacy of traditional Chinese medicine (TCM) for DOR and its potential beneficial effects on fertility. Subjects' (1) Ovarian function (AMH, FSH), (2) Bilateral AFC as shown in pelvic ultrasound, and (3) Traditional Chinese Medicine Symptom Score (TCMSS) will be recorded. It is hypothesized that a 12-week course (5 days medication per week) of TCM herbal therapy for DOR patients will improve one or more of the above aspects when compared to the waiting-list control group.
- Conditions
- Diminished Ovarian Reserve (DOR)
- Being tested
- Yulinzhu (a Chinese Medicinal Formulae)
- Keywords
- Chinese Medicine, diminished ovarian reserve, Yulinzhu
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yulinzhu (a Chinese Medicinal Formulae)Drug
Yulinzhu (毓麟珠) originally published in The Complete Compendium of [Zhang] Jingyue (景岳全書), the mechanisms of action are nourishing kidney essence, qi and blood . The Composition includes: Ginseng Radix et Rhizoma, Atractylodis Macrocephalae Rhizoma, Poria, Paeoniae Radix Alba, Chuanxiong Rhizoma, Glycyrrhizae Radix et Rhizoma, Angelicae Sinensis Radix, Rehmanniae Radix, Cuscutae Semen, Eucommiae Cortex, CervusnipponTemminck, Zanthoxyli Pericarpium.
Both groups will receive Chinese Medicine treatment in form of ready-to-drink packaged Chinese medicine decoction during their treatment period. Subjects will receive Yulinzhu (毓麟珠) with variations allowed. Eight variations can be chosen. The prescription can be edited by applying 2 variations at most every two weeks after TCM consultation.
| Study group | Role | What they receive |
|---|---|---|
| Chinese Medicine herbal treatment group | Experimental | After completing the screening process, Chinese Medicine herbal treatment group will start to receive the Chinese medicine treatment for 12 weeks, during which the TCMSS will be repeated once for every 2 weeks of oral Chinese medicine treatment, for a total of 5 times. At the end of the treatment period, subjects will repeat the same examinations they received before enrollment and enter a waiting list control period for 12 weeks. At the end of the waiting list control period, subjects will repeat the above tests again and undergo IVF treatment after 12 weeks. Receives: Drug: Yulinzhu (a Chinese Medicinal Formulae) |
| waiting-list control group | Other | After completing the screening process, waiting-list control group will enter a 12-week waiting list control period. At the end of the waiting list control period, the subjects will repeat the screening procedures they have undergone before enrollment. Upon completion of the screening process, the subject will start to receive Chinese medicine treatment for a period of 12 weeks, during which the TCMSS will be repeated once for every 2 sessions of oral Chinese medicine treatment, making a total of 5 sessions. At the end of the treatment, subjects in Group B will repeat the above tests and receive IVF treatment. The effect of the intervention will be evaluated by comparing the test data between groups and within groups. Receives: Drug: Yulinzhu (a Chinese Medicinal Formulae) |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum anti-Mullerian hormone (AMH)
For all subjects, on the 2nd to 5th days of the menstrual cycle, 3-5 mL of blood will be collected from the arm-cubital vein once. ELISA (enzyme-linked immunosorbent assay) will be adopted to evaluate the level of AMH.
Measured: will be performed on the first menstrual cycle before treatment, and then at week 12 and 24.
Secondary outcomes (3)
Follicle stimulating hormone (FSH)
For all subjects, on the 2nd to 5th days of the menstrual cycle, 3-5 mL of blood will be collected from the arm-cubital vein once. Electrochemiluminescence will be used to detect the level of serum FSH.
Measured: will be performed on the first menstrual cycle before treatment, and then at week 12 and 24.
Pelvic ultrasound
For all subjects, pelvic ultrasound will be performed on the 2nd to 5th days of the menstrual cycle (on the same day with blood taking) for bilateral ovarian antral follicle count (AFC).
Measured: This assessment will be carried out at baseline, week 12 and week 24.
Traditional Chinese Medicine Symptom Score (TCMSS)
The revised Blatt-Kupperman Menopausal Index will be adopted: (i) Weighting factor: sweating/hot flushes (4 points); paresthesia, sleeplessness, melancholia (categorized as psychological symptoms), dyspareunia, nervousness, urinary tract symptoms (2 points); vertigo, arthralgia/myalgia (categorized as somatic symptoms), fatigue, palpitations, headache, dysesthesia (1 point). (ii) Severity score: asymptomatic (0 point); occasional symptoms (1 point); frequent symptoms (2 points); often and severe symptoms (3 points). (iii) Symptom score = weighting factor × severity score, and the total score is the sum of all symptom scores. (iv)Degree of menopause: mild = 7-15 points; moderate = 16-30 points; severe ≥ 30 points.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start24 Apr 2026
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (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 The University of Hong KongThe 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Kwong Wah Hospital
- Responsible party
- Principal investigator, Dr. Lo Kwai Ching, The University of Hong Kong
- Investigators
- Kwai Ching Lo, Dr, Principal investigator, The Univerisity of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550998
- Sponsor's protocol ID
- DOR20241209
- Acronym
- DOR
- Status last verified
- Jul 2026
- First submitted
- 14 Apr 2026
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided