An Early Phase 1 interventional study of TJAOA101 in Diminished Ovarian Reserve, sponsored by Tongji Hospital. Status unknown at 1 site in China. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2022-10-20.
Sponsored by Tongji Hospital · Early Phase 1, Interventional, and Treatment
Currently, no drugs have been developed for DOR. We developed the Chinese herbal compound TJAOA101 and has validated its effects in animals. Here, we will perform a population-based, multicenter study to confirm the safety and efficacy of TJAOA101 in therapy of DOR. We aim to provide a solid evidence for TCM in therapy of DOR.
As the pivotal reproductive organ, the ovaries have two main functions: ovulation and secretion of hormones. Ovarian dysfunction not only cause reproductive detriment, but also harms to each system and organ, arousing extensive concern of women. Diminished ovarian reserve (DOR) refers to the decline in ovarian function in advance with reduction of functional follicles and the ability to produce high quality oocytes, resulting in reduced fertility and the lack of sex hormones, leading to early menopause and infertility, and accelerated multiple organ aging including osteoporosis, cardiovascular disease, cognitive impairment. As DOR is an early stage of ovarian dysfunction, early intervention is necessary.
Currently, several therapeutic approaches could be considered to prevent and attenuate unfavorable consequences of ovarian function decline. The hormone replacement therapy (HRT) can add exogenous sex hormones by replenishing the lack of hormones to relieve the symptoms caused by low level of estrogen, and then improve the health and life quality. HRT may can bring some benefits to women with DOR. However, it also has some limitations, for instance, it is mainly used for alleviating menopausal symptoms, while not to improve ovarian function. And there are some contraindications, such as breast cancer and blood clots, and HRT may increase the risk of abnormal uterine bleeding(AUB). In addition, dehydroepiandrosterone (DHEA), growth hormone(GH) and aspirin are considered the alternative treatments of DOR. However, due to the lack of large randomized controlled trials, the effectiveness of them needs further confirmation.
Traditional Chinese medicine (TCM) has its own characteristic and superiority in treating diseases, with light side effects and remarkable curative effect. The Chinese nation accumulated a great deal of experience in TCM for treating ovarian dysfunction. Several studies showed that TCM is effective and safe in treating DOR. However, no guidelines for long-term TCM management in treating ovarian function decline exist at present. Clinical trials are imperative to test the safety and efficacy of these TCM prescriptions. And many prescriptions are complicated, mainly rely on the old experience with lacking sufficient scientific basis.
To address this question, we have invented a brand new TCM prescription to treat DOR. Previously, we collected clinical TCM prescriptions from literature retrieval (CNKI and PubMed), and then created a database of recipes for treating ovarian function decline. By using Traditional Chinese Medicine Inheritance Support System (TCMISS) , key TCM and TCM combinations in DPTP were extracted to identify the candidate Chinese herbs. On this basis, gynostemma pentaphylla were added, efficacy and safety of which has been verified in drosophila and mice. Then, TJAOA101 (Tongji Anti-ovarian aging 101), a new TCM recipe was preliminarily developed by multiple experts of pharmacy and gynecology. And multiple model organisms including drosophila, mice of natural aging and chemotherapy damage were further used to verify the safety and effectiveness of TJAOA101 on ovarian function. Finally, the pharmacological action, dose, synergistic effect and incompatibility were determined.
This study is a multicenter and prospective trial aiming to determine the safety and efficacy of TJAOA101 for preventing among women who were diagnosed with DOR. and aims to provide new strategies for improving ovarian reserve and function for DOR patients by evaluating the safety and efficacy of TJAOA1.
Tongji Hospital is the lead sponsor of 373 studies on the registry; 204 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Once enrolled, participants will be administrated TJAOA101 and followed by a 3-month medication cycle. The usage of this herbal compound is to take orally twice a day(two sacks per). Add it to about 200ml warm water and take it half an hour before breakfast in the morning and half an hour before bedtime in the evening except menstrual period.
Drug: TJAOA101
Once enrolled, participants will be administrated TJAOA101
recovery rate of ovarian function
As the definition of DOR is based on AMH or bFSH or AFC, the recovery of ovarian function is also based on the recovery of these indicators. In this study, the recovery of ovarian function is defined as serum AMH increased more than 50%, or serum bFSH decreased more than 50%, or antral follicle count(AFC) increased more than 50% compared with that before treatment，or recover to normal level.
Time frame: 6 months
recovery rate of menstruation
two consecutive periods return to normal.
Time frame: 6 months
This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tongji Hospital