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

NCT06990685 | Not Yet Recruiting Phase 2

• 1 other identifier: KYLL2025357
• Study Type: interventional
• Target: 370
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Salidroside; Randomized Controlled Trial; In Vitro Fertilization; Assisted Reproductive Technology

Outcome Measures

Primary Outcomes (1)

• Ongoing pregnancy rate

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

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

Secondary Outcomes (17)

• Clinical pregnancy rate

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

• Biochemical pregnancy rate

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

• Live birth rate

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

• Embryo implantation rate

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

• Early abortion rate

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

Study Arms (2)

Control group

NO INTERVENTION

Long protocol, short protocol, or antagonist protocol et al.

Experimental Group

EXPERIMENTAL

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.

Drug: Salidroside

Interventions

Salidroside DRUG

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.

Experimental Group

Eligibility Criteria

• Age: 35 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Hospital of Shandong University: lead

Study Sites (1)

The Second Hospital of Shandong University,

Jinan, Shandong, China

Location

MeSH Terms

Interventions

rhodioloside

Study Officials

• Linlin Cui, M.D., Ph.D.

  The Second Hospital of Shandong University, China

  STUDY CHAIR

Central Study Contacts

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

CONTACT

+86 17660083087; geli1128@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 25, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: May 25, 2025

Record last verified: 2025-05

Locations

CN (1)