NCT03120884

Intracytoplasmic Sperm Injection in Non-male Factor Infertility in Advanced Maternal Age

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,422 (estimated)
• Sponsor: International Peace Maternity and Child Health Hospital · Academic / Other
• Sex: Female
• Age: 38 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This will be a prospective, randomized (1:1 ratio) clinical trial for non-male factor infertility in advanced maternal age with or without intracytoplasmic sperm injection(ICSI). Qualified 1422 patients are randomized into either of two groups: group A will undergo conventional in-vitro fertilization(IVF)(711 cases), Group B will undergo intracytoplasmic sperm injection (ICSI) (711 cases). All participants will receive the same protocol for ovarian stimulation and standardized luteal phase support. The target population will be patients with non-male factor infertility aged ≥38years with FSH ≤15. Women with other reasons of infertility (eg. anovulation, endometriosis, and premature ovarian failure) are excluded. The randomization will take place before controlled ovarian stimulation by a computer randomization system. The accumulated live birth rate , pregnancy complications will be followed up by checking medical records and telephone calls.

Conditions

• Infertility, Female
• ART

Interventions

Type	Name	Description
PROCEDURE	ICSI	A technique that involves microinjection of spermatozoa into mature oocytes.
PROCEDURE	IVF	A process of fertilisation where an an egg is combined with sperm outside the body, in vitro.

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-09-01
• Completion: 2019-09-01
• First posted: 2017-04-19
• Last updated: 2017-04-19

Locations

1 site across 1 country: China