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Preimplantation Genetic Screening in Patients With Male Factor Infertility

NCT02941965 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2022-06-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • International Peace Maternity and Child Health Hospital

    lead OTHER

Principal Investigators

  • He-Feng Huang · Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-18
Primary Completion
2022-08-30
Completion
2023-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02941965 on ClinicalTrials.gov