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Elucidating the Mechanism of Er-Zhi Tian-Gui Formula in Improving In Vitro Fertilization-Embryo Transfer (IVF-ET) Outcomes in Elderly Women Through Transcriptome-Metabolome Analysis.

Elucidating the Mechanism of Er-Zhi Tian-Gui Formula in Improving In Vitro Fertilization-Embryo Transfer (IVF-ET) Outcomes in Elderly Women Through Transcriptome-Metabolome Analysis.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000616
Enrollment
Unknown
Registered
2026-03-19
Start date
2026-01-31
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The diminished ovarian reserve in advanced age.

Interventions

Young control group:GnRH-ant protocol for controlled ovarian stimulation
administration of r-FSH (Gonal-f, Merck Serono) begins on day 2-3 of the menstrual cycle to stimulate follicular growth. During the ovulation induction process, the dosage of r-FSH is adjusted based o
Elderly control group:GnRH-ant protocol for controlled ovarian stimulation
Elderly Chinese medicine group:GnRH ant protocol controlled ovarian stimulation
. When at least three dominant follicles were = 18mm, GnRH-a and r-FSH were stopped, 10000 IU of human chorionic gonadotropin (hCG) was injected intramuscularly to trigger oocyte maturation, and the e

Sponsors

Shandong University of Traditional Chinese Medicine Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
21 Years to 42 Years

Inclusion criteria

Inclusion criteria: Young control group: 1. Patients with infertility undergoing IVF-ET; 2. Age between 21 and 35 years old; 3. AMH = 1.2 ng/mL; 4. Signed informed consent, voluntarily participating in this study and actively cooperating. Older control group and older medication group: 1. Patients with infertility undergoing IVF-ET; 2. Age between 35 and 42 years old; 3. AFC < 5 and AMH < 1.2 ng/mL; 4. Signed informed consent, voluntarily participating in this study and actively cooperating.

Exclusion criteria

Exclusion criteria: 1. BMI = 28 kg/m²; 2. Chromosomal abnormalities in both partners' karyotypes, infertility caused by genetic factors; 3. Suffering from polycystic ovary syndrome, endometriosis, hyperprolactinemia, uterine fibroids, or other gynecological diseases; congenital or acquired uterine developmental abnormalities, and other contraindications for assisted reproductive technology; 4. Use of any steroid hormone medications in the past 3 months prior to enrollment; 5. Severe systemic diseases (physical or mental) in the female partner that make pregnancy unbearable; history of radiotherapy or chemotherapy; 6. Currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Number of Retrieved Oocytes;

Secondary

MeasureTime frame
Gonadotropin administration time;Total gonadotropin dose;Average dosage of gonadotropin;Serum estradiol on trigger day;Serum progesterone on trigger day;Normal fertilization number;Number of transferable embryos;Number of high-quality embryos;Mature Oocyte Rate / MII Oocyte Rate;Cancellation cycle rate;Positive pregnancy;Implantation rate;Clinical pregnancy;

Countries

China

Contacts

Public ContactGuo Ying

Shandong University of Traditional Chinese Medicine Affiliated Hospital

71000916@sdutcm.edu.cn13864138647

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Apr 4, 2026