Yulinzhu for Women With Diminished Ovarian Reserve

Официальное название

Yulinzhu for Women With Diminished Ovarian Reserve: a Randomized, Waiting-list Controlled, Crossover Trial

Обзор

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.

Вмешательства

• Препарат Yulinzhu (a Chinese Medicinal Formulae)
  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 tre

Первичные конечные точки

• serum anti-Mullerian hormone (AMH) [Срок оценки: will be performed on the first menstrual cycle before treatment, and then at week 12 and 24.]

Вторичные конечные точки (3)

• Follicle stimulating hormone (FSH) [Срок оценки: will be performed on the first menstrual cycle before treatment, and then at week 12 and 24.]
• Pelvic ultrasound [Срок оценки: This assessment will be carried out at baseline, week 12 and week 24.]
• Traditional Chinese Medicine Symptom Score (TCMSS) [Срок оценки: Up to 18 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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:

(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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Гонконг · 2 центра

• Kwung Wah Hospital — Гонконг
• Queen Marry Hosipital — Гонконг

Идентификаторы

NCT: NCT07550998 · DOR20241209

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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