NCT02941965

Preimplantation Genetic Screening in Patients With Male Factor Infertility

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: International Peace Maternity and Child Health Hospital · Academic / Other
• Sex: Male
• Age: 20 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This will be a prospective, randomized (1:1 ratio) clinical trial for patients with severe male-factor infertility with or without preimplantation genetic screening (PGS). Qualified 450 patients are randomized into either of two groups: group A will undergo intracytoplasmic sperm injection (ICSI) without PGS (225 cases), Group B will undergo ICSI with PGS (225 cases). The partners of all participants will receive the same protocol for ovarian stimulation and standardized luteal phase support. The target population will be patients with severe male-factor infertility aged between 20 and 55 years, diagnosed by the ESHER Criteria (Non-obstructive oligospermia，asthenspermia). Women with other reasons of infertility (eg. advanced age, anovulation, endometriosis, and premature ovarian failure) are excluded. The randomization will take place 3-6 days after the oocyte pick-up day by a computer randomization system. The pregnancy test results, pregnancy complications, congenital anomalies, neonatal complications will be followed up by checking medical records and telephone calls.

Conditions

• Infertility, Male
• Diagnosis, Preimplantation

Interventions

Type	Name	Description
PROCEDURE	ICSI without PGS	Selection of embryos are based on morphology criteria on the 5th day of ICSI.
PROCEDURE	ICSI with PGS	PGS will be applied to selected embryos on the 5th day of ICSI.

Timeline

• Start date: 2017-07-18
• Primary completion: 2022-08-30
• Completion: 2023-06-30
• First posted: 2016-10-21
• Last updated: 2022-06-06

Locations

1 site across 1 country: China