Fertility problem
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female age 20 =35 years: (1) Indications for PGT-A: 1) Advanced maternal age (AMA, >=35 years); 2) Recurrent implantation failure (RIF: >=3 failed embryo transfers, or failure after transfer of 4–6 high-quality cleavage-stage embryos, or >=3 high-quality blastocysts); 3) Recurrent spontaneous abortion (RSA: >=2 consecutive pregnancy losses before 28 weeks of gestation); (2) Indications for PGT-M: 1) Monogenic disorders; 2) HLA matching; 3) Severe inherited conditions with high penetrance; (3) Indications for PGT-SR: 1) Either or both partners carry chromosomal structural abnormalities, including reciprocal translocations, non- Robertsonian translocations, inversions, complex rearrangements, pathogenic microdeletions, or microduplications; 3. Agreement to single blastocyst cryopreservation and frozen-thawed embryo transfer; 4. First or second PGT stimulation cycle; 5. According to the 2010 WHO criteria, male semen parameters are normal (sperm concentration >=15*10^6/mL, total motility >=32%), or exhibit only one of the following mild abnormalities: (1) Oligoasthenospermia (sperm concentration 5–15*10^6/mL, total motility 10–32%); (2) Oligospermia (sperm concentration 5–15*10^6/mL, total motility >=32%); (3) Asthenospermia (sperm concentration >=15*10^6/mL, total motility 10–32%); 6. Full informed consent obtained from the patient.
Exclusion criteria
Exclusion criteria: 1. Use of frozen oocytes or frozen sperm, teratozoospermia with head defects, or two consecutive semen analyses showing normal morphology 4 cm in diameter, benign pelvic/abdominal tumors >4 cm, endometrial thickness <7 mm, pituitary tumors, malignancies of any organ, severe adenomyosis, or moderate-to-severe intrauterine adhesions; 6. Contraindications to IVF: uncontrolled diabetes, unexplained liver or renal dysfunction, uncontrolled hypertension, symptomatic cardiac disease, history of deep vein thrombosis, pulmonary embolism, or cerebrovascular accident; 7. Couples in which the monogenic disorder is caused by large-scale gene deletions or duplications (e.g., a-thalassemia, spinal muscular atrophy) or complex structural rearrangements; 8. Patients currently enrolled in other clinical trials; 9. Any other condition deemed unsuitable for participation in this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cumulative live birth rate;Day3 good embryo number; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fertilization rate;2PN Fertilization rate;Biopsied blastocyst number;Genetically transferable blastocyst rate;Consistency rate between blastocyst results and prenatal diagnosis results;Clinical pregnancy rate;Twin pregnancy rate;Continuous pregnancy rate;Live birth rate;Time to live birth;Good birth outcome rate;Consistency rate of prenatal diagnostic results; | — |
Countries
China
Contacts
Guangdong Women and Children Hospital