infertility of advanced-age women
Conditions
Interventions
experimental group :The patients in the experimental group started the GH treatment regimen on days 2-5 of their menstrual cycle: 27 IU per dose, with a frequency of once a week, until the pregnancy t
control group:Clinical routine protocol for endometrial preparation and luteal phase support
Sponsors
The Sixth Affiliated Hospital of Sun Yat-sen University
Eligibility
Sex/Gender
Female
Age
37 Years to 43 Years
Inclusion criteria
Inclusion criteria: (1) Women aged 37-43 years; (2) at least one frozen high-quality blastocyst (grading 3BB or above); (3) BMI in the range of 18-25 kg/m²; (4) Signed the informed consent form; (5) Willing to follow the research plan and complete the study.
Exclusion criteria
Exclusion criteria: (1) Recurrent implantation failure: Prior history of transferring >=3 high-quality embryos or at least 10 viable embryos and still failing to achieve clinical pregnancy; (2) History of two or more spontaneous miscarriages; (3) Unexplained abnormal vaginal bleeding; (4) Screening based on medical history or gynecological ultrasound indicating the following clinically significant conditions: Uterine and endometrial lesions, including submucosal fibroids, uterine fibroids >=3 cm, endometrial polyps >=1 cm, intrauterine adhesions affecting pregnancy as assessed by the investigator, uterine abnormalities, etc.; Ovarian and adnexal lesions, such as ovarian cysts >3 cm in diameter, hydrosalpinx affecting pregnancy as assessed by the investigator; History of surgery confirming ASRM stage III-IV endometriosis; (5) Screening visit reveals alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels greater than twice the upper limit of normal; (6) Participation in any other clinical trials within three months prior to the start of this study (to ensure adequate washout of previously used external research drugs); (7) Severe infections, major trauma, or major surgical operations within six months prior to screening; (8) Any disease or symptom known to affect systemic body function and potentially interfere with the absorption, excessive accumulation, metabolism, or excretion of study drugs; (9) Severe systemic diseases, uncontrolled endocrine disorders (including but not limited to TSH >2.5 mU/L), or metabolic abnormalities (including but not limited to fasting blood glucose >6.1 mmol/L, fasting insulin >10 IU/mL); (10) History of thromboembolic disease or past thromboembolic disease; (11) Malignant tumors or history of malignancy (excluding basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ), or high risk of malignancy occurrence or recurrence; (12) Breast nodules classified as category 3 or higher; (13) History of known severe mental illness or inability to understand the purpose, methods, etc., of this clinical trial, as well as non-compliance with study protocols; (14) Contraindications or other conditions listed in the approved drug instructions for the use of growth hormone in China: allergies to experimental drugs or any excipients; confirmed or suspected tumors; (15) Other reasons deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| HCG positive rate;clinical pregnancy rate;embryo implantation rate;miscarriage rate; | — |
Countries
China
Contacts
Public ContactXiaoyan Liang
The Sixth Affiliated Hospital of Sun Yat-sen University
Outcome results
None listed