Preimplantation Genetic Screening in Patients With Male Factor Infertility

Not Applicable

• Conditions: Infertility, Male; Diagnosis, Preimplantation
• Interventions: Procedure: ICSI with PGS; Procedure: ICSI without PGS

• Registration Number: NCT02941965
• Lead Sponsor: International Peace Maternity and Child Health Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-19
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-21
• Study Start: 2017-07-18
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-01
• Last Update Posted: 2022-06-06
• Primary Completion: 2022-08-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 450

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ICSI with PGS	ICSI with PGS	PGS will be applied to select embryos on day 5, only euploid embryos will be transferred. A maximum of 2 embryos will be transferred for each treatment cycle.
ICSI without PGS	ICSI without PGS	Selection of embryos are based on blastocyst morphology criteria on day 5. A maximum of 2 embryos will be transferred for each treatment cycle.

Primary Outcome Measures

Name	Time	Method
live birth rate	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 Outcome Measures

Name	Time	Method
pregnancy loss rate	28 gestational weeks in maximum	Pregnancy loss is defined as any reason that resulted in failure of an embryo to develop, embryonic or fetal death, or spontaneous expulsion of a pregnancy.
ectopic pregnancy rate	12 gestational weeks in maximum	Ectopic pregnancy is defined as an embryo implanted outside the uterine.
implantation rate	11-12 weeks after embryo transfer	Implantation rate was defined as the percentage of fetal heart beat among total transferred embryos at 12 weeks' gestational age.
clinical pregnancy rate	35 days after embryo transfer	Clinical pregnancy was defined as an observation of gestational sac via ultrasonography.
biochemical pregnancy rate	2 weeks after embryo transfer	Biochemical pregnancy was defined as numbers of women with an elevated serum β-hCG level of more than 10 mIU/ml.
neonatal complication rate	1 day after delivery	Neonatal complication includes neonatal respiratory disorders, neonatal cerebral palsy, neonatal encephalopathy and other disease that should been sent into neonatal ICU.
Congenital Anomalies rate	1 day after delivery	Congenital anomaly included deformity and development abnormality of any organs or systems.

Trial Locations

Locations (1)

International Peace Maternity & Child Health Hospital; 🇨🇳 Shanghai, Shanghai, China