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NCT06990685
Effect of Salidroside on Pregnancy Outcomes in High Childbearing Age Patients in Viro Fertilization: an Open-label Randomized Controlled Trial
Phase 2 trial testing Salidroside in Salidroside in 370 participants. Not yet recruiting.
1 January 2027
Quick facts
| Lead sponsor | The Second Hospital of Shandong University |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 370 |
| Start date | 1 June 2025 |
| Primary completion | 1 January 2027 |
| Estimated completion | 1 December 2027 |
| Sites | 1 location across China |
Drugs / interventions tested
- Salidroside — full drug profile →
Conditions studied
- Salidroside — all drugs for Salidroside →
- Randomized Controlled Trial — all drugs for Randomized Controlled Trial →
- In Vitro Fertilization — all drugs for In Vitro Fertilization →
- Assisted Reproductive Technology — all drugs for Assisted Reproductive Technology →
Sponsor
The Second Hospital of Shandong University
Who can join
Adults 35 to 39, female only, with Salidroside or Randomized Controlled Trial. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Ongoing pregnancy rate
Time frame: from transplantation to delivery (assessed up to 40 weeks of gestation)
The number of continuous pregnancy cycles divided by the number of frozen embryo transfer cycles
Sponsor's own description
With the decreasing of birth rate and population in our country, population problem has become a long-term and strategic problem. In addition to the decrease in the number of women of childbearing age and the impact of unmarried women, the increase in the incidence of reproductive disorders and the delay of marriage and childbearing are also important factors leading to the continuous decline of the birth population in China. Among them, ovarian aging is a key factor causing female fertility difficulties. Therefore, establishing an effective prevention and treatment strategy for ovarian aging is of great significance for improving female reproductive health and serving the national population strategy. Recently, several supplements have been found to promote folliculogenesis and improve oocyte quality. However, to date, there is no approved therapeutic agent for the treatment of ovarian aging. Therefore, it is urgent to develop effective strategies for the prevention and treatment of ovarian aging. Salidroside is the main active component of Chinese medicine Rhodiola, and its content is highest in the root of rhodiola, which is also the main medicinal part. The main efficacy of salidroside in traditional Chinese medicine is to benefit qi, promote blood circulation, unblock pulse and relieve asthma. At the same time, in basic research, more and more experiments have shown that salidroside has a variety of pharmacological properties, including anti-hypoxia, anti-fatigue and anti-aging effects, anti-cancer, anti-inflammatory, anti-oxidation, antiviral and so on. These pharmacological effects suggest that salidroside may be an effective drug for the prevention and treatment of atherosclerosis, Parkinson's disease, Alzheimer's disease, pneumonia and other diseases. In terms of aging, it has been confirmed that salidroside supplementation can prolong the life span of pseudogill oryzias zhan and rescue premature aging of human skin fibroblasts, etc., which further confirms. The aim of this study is to investigate the efficacy of salidroside as an adjuvant drug in improving the pregnancy outcomes of fresh embryo transfer in high childbearing age patients with poor ovarian response by comparing the pregnancy outcomes of fresh embryo transfer between salidroside group and blank control group. This pragmatic clinical study is expected to improve pregnancy outcomes of fresh embryo transfer cycles in women of advanced childbearing age with poor ovarian response.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06990685 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Second Hospital of Shandong University
- Last refreshed: 22 May 2025
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