Preimplantation Genetic Screening in Patients With Male Factor Infertility
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.
Investigators
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)