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SalidrosidePhase 2NCT06990685

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

A Phase 2 study testing Salidroside in people with Salidroside and Randomized Controlled Trial, run by The Second Hospital of Shandong University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 35 to 39 years, women only
What is being tested?
Salidroside
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
370 participants
Where
1 siteChina
Study dates
1 Jun 2025to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 39 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age ≥35 and < 40 years old
  • For the first or second cycle of IVF, ICSI or IVF with donor sperm
  • 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.

Who cannot join

  • Patients with coagulation disorders
  • Patients with previous abnormal uterine bleeding
  • Combined with hydrosalpinx confirmed by B-ultrasound and HSG
  • Uterine malformation (unicornuate uterus, septate uterus) or history of intrauterine adhesions
  • Patients with previous spontaneous abortion ≥3 times
  • Patients with contraindications to assisted reproductive technology or pregnancy
  • Previous or current oral medication containing salidroside
  • The controlled ovarian stimulation protocol included PPOS protocol, luteal phase ovulation induction protocol, and continuous stimulation protocol

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Li Ge, M.D., Ph.D. contact

+86 17660083087

geli1128@163.com

China1 site
  • The Second Hospital of Shandong University,

    Jinan, Shandong

Other trials in China

About this study

Official title: Effect of Salidroside on Pregnancy Outcomes in High Childbearing Age Patients in Viro Fertilization: an Open-label Randomized Controlled Trial

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.

Read the detailed description

With the continuous decline in China's birth rate and number of births in recent years, the population issue has become a long-term and strategic issue in China. In addition to the impact of the decrease in the number of women of childbearing age and the non-marriage, the increase in the incidence of reproductive disorders and the postponement of the age of marriage and childbearing are also important factors leading to the continuous decline in the number of births in China. Among them, ovarian aging is a key factor causing fertility difficulties in women. Therefore, it is of great significance to establish an effective ovarian aging prevention and treatment strategy to improve women's reproductive health and serve the national population strategy. Recently, studies have found that a variety of supplements can promote follicular genesis and improve oocyte quality. However, to date, there are no approved effective treatments for ovarian aging. Therefore, it is urgent to develop effective strategies for the prevention and treatment of ovarian aging. Salidroside is the most active ingredient of Rhodiola rosea in traditional Chinese medicine, and has the highest content in the root of Rhodiola rosea, which is also the main medicinal site. The main effects of salidroside in traditional Chinese medicine are to invigorate qi and blood, and to 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 effects, anti-inflammatory effects, antioxidant effects, antiviral effects, etc. 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 supplementation of salidroside can prolong the life of Pseudogill medaka and save the premature aging of human skin fibroblasts, which further confirms the anti-aging effect and potential application value of salidroside. In the process of clinical assisted reproduction, the proportion of elderly women has been increasing in recent years; Due to the significant decline of female ovarian function in middle age, the success rate of assisted reproduction in elderly women has always been at a low level. However, whether in animal model studies or in human tissue sections, it is generally believed that there are still a large number of follicles in the ovaries of middle-aged females or females that are sufficient to support reproductive activities, but because the physiological reasons for the decline of ovarian function in middle-aged women are unknown, the contradiction of abundant follicles but declining ovarian function in middle-aged women cannot be overcome.Recently, Zhang Hua's team in China used high-resolution ovarian organ imaging technology combined with genetically modified animal models, single-cell omics and drug screening to reveal that the ovaries have specific vascular degeneration in middle age, which leads to a decrease in ovarian blood supply, stunted follicle development, and ultimately a decline in fertility. Mechanistic studies have confirmed that ovarian vascular endothelial aging is the cause of ovarian vascular degeneration in middle age. Based on the above findings, through the screening of a large number of natural products, it was found that in vitro treatment of salidroside can improve the regeneration ability of follicular blood vessels without affecting the development of follicles. Continuous injection of salidroside in vivo can significantly improve the ability of ovarian angiogenesis in elderly mice, improve ovarian blood supply, and then promote follicle development, increase the quantity and quality of ovulation in advanced mice, and increase the number of births in elderly mice. The safety evaluation proved that salidroside treatment had no effect on the blood vessels of heart, kidney, liver and other organs, and long-term (12 months) monitoring showed that there was no abnormal organ development and tumor production in mice after salidroside treatment. Other teams, using different in vitro and in vivo models, have also found that salidroside supplementation can improve oocyte quality in mice or pigs. On the one hand, the addition of salidroside to oocytes cultured in vitro can improve the maturation, fertilization and development ability of oocytes of childbearing age by maintaining normal spindle/chromosome structure and mitochondrial function, including improving oocyte spindle/chromosome arrangement, mitochondrial and cortical particle distribution, mitochondrial membrane potential, and reducing reactive oxygen species. On the other hand, it can also improve the oocyte quality of reproductive elderly mice by enhancing mitophagy, including improving their oocyte genesis, maturation, fertilization and embryonic development potential. The above studies provide a solid theoretical basis for salidroside to improve the quality of female oocytes. In summary, salidroside can improve oocyte quality and fertility through a variety of mechanisms. However, current research is still limited to animal experiments, and in-depth clinical evidence is lacking. Therefore, it is necessary to further explore the effect of salidroside on ovarian function, promote the clinical transformation of basic research, and serve the national population strategy.

Being tested
Salidroside

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SalidrosideDrug

    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 groups in NCT06990685
Study groupRoleWhat they receive
Control groupNo interventionLong protocol, short protocol, or antagonist protocol et al.
Experimental GroupExperimentalIn 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.
Receives: Drug: Salidroside

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ongoing pregnancy rate

    The number of continuous pregnancy cycles divided by the number of frozen embryo transfer cycles

    Measured: from transplantation to delivery (assessed up to 40 weeks of gestation)

Secondary outcomes (17)
  1. Clinical pregnancy rate

    The number of clinical pregnancy cycles divided by the number of transplantation cycles

    Measured: from transplantation to delivery (assessed up to 40 weeks of gestation)

  2. Biochemical pregnancy rate

    The number of biochemical pregnancy cycles divided by the number of transplantation cycles

    Measured: from transplantation to delivery (assessed up to 40 weeks of gestation)

  3. Live birth rate

    The number of live birth cycles divided by the number of transplantation cycles

    Measured: from transplantation to delivery (assessed up to 40 weeks of gestation)

  4. Embryo implantation rate

    The ratio of the number of gestational sacs observed by ultrasound to the number of transplanted embryos

    Measured: from transplantation to delivery (assessed up to 40 weeks of gestation)

  5. Early abortion rate

    The ratio of the number of spontaneous abortion cycles to the number of clinical pregnancy cycles within 12 weeks of gestation

    Measured: from transplantation to abortion (assessed up to 12 weeks of gestation)

  6. Ectopic pregnancy

    The embryo implants and grows and develops anywhere other than the uterine cavity

    Measured: from transplantation to delivery (assessed up to 40 weeks of gestation)

  7. Pregnancy loss

    Natural termination of clinical pregnancy or therapeutic induction of labor before 28 weeks of gestation

    Measured: from transplantation to abortion (assessed up to 28 weeks of gestation)

  8. Stillbirth

    A baby without vital signs is delivered at 28 weeks or more of gestation

    Measured: from transplantation to delivery (assessed up to 40 weeks of gestation)

  9. Preterm birth

    Delivery before 37 weeks of gestation

    Measured: from transplantation to delivery (assessed up to 37 weeks of gestation)

  10. Gestational diabetes mellitus

    Abnormalities of glucose metabolism of different degrees that first occur and are discovered during pregnancy

    Measured: from transplantation to delivery (assessed up to 40 weeks of gestation)

  11. Preeclampsia

    After 20 weeks of gestation, if a pregnant woman has a systolic blood pressure of ≥140 mmHg and/or a diastolic blood pressure of ≥90 mmHg, accompanied by any one of the following: urine protein quantification ≥0.3 g/24 h, or the urine protein/creatinine ratio ≥0.3, or random urine protein ≥(+)(the examination method when protein quantification is not performed unconditionally); There is no proteinuria but any one of the following organs or systems is involved: important organs such as the heart, lungs, liver, and kidneys, or abnormal changes in the blood system, digestive system, and nervous system, or the placenta and fetus are involved, etc.

    Measured: from transplantation to delivery (assessed up to 40 weeks of gestation)

  12. Hypertension in Pregnancy

    Hypertension first occurred after 20 weeks of pregnancy, with a systolic blood pressure of ≥140 mmHg (1 mmHg=0.133 kPa) and/or a diastolic blood pressure of ≥90 mmHg; The urine protein test was negative

    Measured: from transplantation to delivery (assessed up to 40 weeks of gestation)

  13. Premature rupture of membranes

    It refers to the spontaneous rupture of the fetal membranes before labor. According to the gestational age at which it occurs, it is divided into full-term fetal membranes and preterm premature rupture of fetal membranes

    Measured: from transplantation to delivery (assessed up to 40 weeks of gestation)

  14. Placenta previa

    The lower edge of the placenta is adjacent to or covers the internal OS of the cervix

    Measured: from transplantation to delivery (assessed up to 40 weeks of gestation)

  15. Placental abruption

    The placenta in its normal position partially or completely separates from the uterine wall before the fetus is delivered

    Measured: from transplantation to delivery (assessed up to 40 weeks of gestation)

  16. Postpartum Hemorrhage

    Within 24 hours after the delivery of the fetus, the amount of blood loss in parturients with vaginal delivery is ≥500 ml, the amount of blood loss in parturients with cesarean section is ≥ 1,000 ml, or there are symptoms or signs of hypovolume after blood loss

    Measured: Within 24 hours after childbirth

  17. Neonatal death

    Infants with vital signs at birth die within 28 days after birth

    Measured: Within 28 days after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2025
  2. Study start1 Jun 2025 (estimated)
  3. Primary completionJan 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
370 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06990685
Sponsor's protocol ID
KYLL2025357
Status last verified
May 2025
First submitted
21 Apr 2025
Last updated
25 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Salidroside in people with Salidroside and Randomized Controlled Trial, run by The Second Hospital of Shandong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Li Ge, M.D., Ph.D. (+86 17660083087, geli1128@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ongoing pregnancy rate (time frame: from transplantation to delivery (assessed up to 40 weeks of gestation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.

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