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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age35-39
SponsorThe Second Hospital of Shandong University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

370 Participants
are divided into 2 treatment groups
Group A: Control groupNo intervention 0 interventions
Group B: Experimental GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Ongoing pregnancy rate

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

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

Secondary outcomes

1

Clinical pregnancy rate

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

Time frame
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

Time frame
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

Time frame
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

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

Other outcomes

Sponsors and contacts

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