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Starting soon Phase 2

Effect of Salidroside on Pregnancy Outcomes in High Childbearing Age Patients in Viro Fertilization

NCT06990685 · tracked via the Priya Life Science China tracker
Phase
Phase 2
Started
2025-06-01
Last updated
2025-05-25

Condition(s) studied

SalidrosideRandomized Controlled TrialIn Vitro FertilizationAssisted Reproductive Technology

Investigational drug(s) / intervention(s)

Salidroside

Salidroside: In the salidroside group, oral administration of rhodiola capsules (Xizang Gaoyuan 'an Biotechnology Development Co., LTD.) was started on the day of entering the COS cycle, once a day, 2 pills at a time, and the drug was stopped on the trigger day.

Study summary

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.

Eligibility

Sex
FEMALE
Min age
35 Years
Max age
39 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age ≥35 and \< 40 years old 2. For the first or second cycle of IVF, ICSI or IVF with donor sperm 3. According to the 2016 Poseton criteria for poor prognosis: the number of oocytes obtained in the previous routine ovulation induction protocol was 1-9, or AFC \< 5 or AMH \< 1.2ng/ml (measured within the past half year) in both ovaries. Exclusion Criteria: 1. Patients with coagulation disorders 2. Patients with previous abnormal uterine bleeding 3. Combined with hydrosalpinx confirmed by B-ultrasound and HSG 4. Uterine malformation (unicornuate uterus, septate uterus) or history of intrauterine adhesions 5. Patients with previous spontaneous abortion ≥3 times 6. Patients with contraindications to assisted reproductive technology or pregnancy 7. Previous or current oral medication containing salidroside 8. The controlled ovarian stimulation protocol included PPOS protocol, luteal phase ovulation induction protocol, and continuous stimulation protocol

Primary outcome measure(s)

  • Ongoing pregnancy rate — 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

Trial sites (1)

FacilityCityRegionStatus
The Second Hospital of Shandong University, Jinan Shandong
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06990685 on ClinicalTrials.gov ↗ ← All trials in China