Yulinzhu for Women With Diminished Ovarian Reserve

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 randomized, waiting-list controlled crossover trial evaluating traditional Chinese medicine as a treatment for diminished ovarian reserve. Participants will receive a 12-week course of Yulinzhu herbal therapy (5 days per week) and have ovarian function measures and symptom scores tracked, with a waiting-list group serving as control. Primary outcomes include ovarian reserve markers (AMH, FSH), antral follicle count by ultrasound, and the Chinese Medicine Symptom Score. The trial design allows comparison of treatment effects against delayed treatment, and all participants may pursue IVF after the study if pregnancy does not occur spontaneously. Enrollment targets include women aged 18-40 meeting specific ovarian reserve criteria and infertility-related conditions, with exclusions including prior oophorectomy and recent TCM use for DOR.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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.) ;
2. Tests of ovarian reserve within 6 months:

   1. AMH \< 1.1 ng/ml or (any day in cycle, refer to laboratory standards);
   2. AFC \< 7 follicles or (any day in cycle);
   3. Received \<3 cycles of IVF in public sector;
3. Subject has no history of allergy to TCM;
4. Subjects agree to receive IVF treatment upon the completion of this research within 12 weeks if they are not pregnant spontaneously; and
5. As diagnosed by Chinese Medicine practitioner through four diagnostic methods, suitable to receive Yulinzhu.

Exclusion Criteria:

1. Previous history of a unilateral or bilateral oophorectomy;
2. Recent administration of TCM for DOR within 3 months;
3. Diagnosis of pregnancy, premature ovarian failure, residual follicles, cysts or space-occupying lesions in the ovary, pelvic inflammatory disease or polycystic ovary syndrome; and
4. Cancer, untreated thyroid dysfunction, severe cardiovascular/cerebrovascular diseases, severe liver/kidney diseases or hematopoietic system diseases.
5. Subjects are allowed to withdraw from the trial for one of the following reasons:

(1) 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.

Where it's running

• Queen Marry Hosipital
  Hong Kong, Hong Kong Recruiting
• Kwung Wah Hospital
  Hong Kong, Hong Kong Not yet recruiting

Study contacts

• Principal investigator: Kwai Ching Lo, Dr — The Univerisity of Hong Kong
• Study coordinator: Kwai Ching Lecturer, PHD
• Email: angelos@hku.hk
• Phone: +852 3917 6462

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• G-CSF for DOR in women undergoing IVF

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• Bushen Yiqi herbal formula plus DHEA for women with diminished ovarian reserve

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• Tongue and gut bacteria patterns in women with diminished ovarian reserve

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  Recruiting Hangzhou TCM Hospital Affiliated to Zhejiang Chinese Medical University · Hangzhou, Zhejiang · NCT07124260

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.