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Comparation of conventional in-vitro fertilization and intracytoplasmic sperm injection in couples undergoing pre-implantation genetic testing: a multicenter, open-label, randomized controlled trial

Comparation of conventional in-vitro fertilization and intracytoplasmic sperm injection in couples undergoing pre-implantation genetic testing: a multicenter, open-label, randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110236
Enrollment
Unknown
Registered
2025-10-10
Start date
2025-11-19
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Fertility problem

Interventions

c-IVF group:Conventional in vitro fertilization

Sponsors

Guangdong Women and Children Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 40 Years

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

MeasureTime frame
Cumulative live birth rate;Day3 good embryo number;

Secondary

MeasureTime 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

Public ContactLiu Fenghua

Guangdong Women and Children Hospital

liushine2006@163.com+86 139 2647 8318

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026