Poor Embryo Quality in Previous Assisted Reproductive Technology (ART) CyclesDefinition and Diagnostic Criteria:This condition refers to patients who, in one or two prior IVF/ICSI cycles, achieved an adequate number of normally fertilized embryos (>=4) under sufficient gonadotropin stimulation, but demonstrated a Day 3 (D3) top-quality embryo rate of <=25%.
Conditions
Interventions
Control group:4-week growth hormone pretreatment
Treatment group:12-week growth hormone pretreatment
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Age 20–40 years; 2. Body mass index (BMI) 18–28 kg/m^2; 3. Regular menstrual cycles (25–35 days); 4. Anti-Müllerian hormone (AMH) >=1.1 ng/mL or antral follicle count (AFC) >=4; 5. Prior history of <=2 IVF/ICSI cycles; 6. In the previous IVF/ICSI cycle, at least 4 normally fertilized embryos were obtained under adequate gonadotropin stimulation, with a Day 3 top-quality embryo rate <=25%; 7. The cycle with poor embryo quality occurred within 1 year prior to enrollment; 8. Voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Chromosomal abnormalities in either partner (except for polymorphisms); 2. History of >=2 spontaneous abortions in the female partner; 3. Patients with polycystic ovary syndrome (PCOS); 4. Male partner requiring surgical sperm retrieval; 5. Male partner with sperm DNA fragmentation index >=30%; 6. Patients planning to undergo preimplantation genetic testing (PGT); 7. Participation in another clinical trial within the past 3 months; 8. Use of growth hormone within the past 3 months; 9. Gynecological conditions affecting pregnancy outcomes: untreated hydrosalpinx, thin endometrium (=5 cm, ovarian cysts >=5 cm of undetermined nature, severe endometriosis, uterine malformations or abnormalities (septate uterus, unicornuate uterus, bicornuate uterus, mild-to-moderate intrauterine adhesions without surgical treatment, severe intrauterine adhesions, submucosal uterine fibroids, endometrial polyps without surgical treatment, genital tuberculosis, etc.); 10. Other internal or surgical diseases: immune disorders, diabetes mellitus, breast nodules (BI-RADS grade >=IV on ultrasound), thyroid nodules (TI-RADS grade >=IV on ultrasound), etc; 11. History of definite or suspected malignant tumors at any site.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical pregnancy rate in the first embryo transfer cycle (fresh or frozen embryo transfer); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration and dosage of gonadotropin use;Endometrial thickness on HCG day;Number of oocytes retrieved;Number of mature MII oocytes;Two-pronuclei fertilization rate;Number of viable embryos on day 3;Viable embryo rate on day 3;Number of high-quality embryos on day 3;High-quality embryo rate on day 3;Number of blastocysts formed;Blastocyst formation rate;Number of high-quality blastocysts;High-quality blastocyst formation rate;Pregnancy outcomes in the first embryo transfer cycle (HCG positivity rate, implantation rate, early spontaneous abortion rate, ongoing pregnancy rate >=12 weeks, live birth rate);Cumulative pregnancy rate per oocyte retrieval cycle;Cumulative live birth rate per oocyte retrieval cycle;Incidence of pregnancy-related complications;Incidence of fetal abnormalities at birth (defects, diseases, low birth weight, macrosomia, etc.); | — |
Countries
China
Contacts
Public ContactHuang Xuefeng
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed