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Clinical Trials/NCT02941965
NCT02941965
Unknown
Not Applicable

Preimplantation Genetic Screening in Patients With Male Factor Infertility

International Peace Maternity and Child Health Hospital1 site in 1 country450 target enrollmentJuly 18, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility, Male
Sponsor
International Peace Maternity and Child Health Hospital
Enrollment
450
Locations
1
Primary Endpoint
live birth rate
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
July 18, 2017
End Date
June 30, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
International Peace Maternity and Child Health Hospital
Responsible Party
Principal Investigator
Principal Investigator

He-Feng Huang

President

International Peace Maternity and Child Health Hospital

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

live birth rate

Time Frame: 42 weeks

This will be based on the outcome of either the PGS+ICSI or the outcome of the ICSI after first embryo transfer cycle.

Secondary Outcomes

  • pregnancy loss rate(28 gestational weeks in maximum)
  • ectopic pregnancy rate(12 gestational weeks in maximum)
  • implantation rate(11-12 weeks after embryo transfer)
  • clinical pregnancy rate(35 days after embryo transfer)
  • biochemical pregnancy rate(2 weeks after embryo transfer)
  • neonatal complication rate(1 day after delivery)
  • Congenital Anomalies rate(1 day after delivery)

Study Sites (1)

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