Status:
SUSPENDED
Evaluating Piezo-ICSI. - The EPI Study.
Lead Sponsor:
Vitrolife
Conditions:
IVF
Infertility
Eligibility:
All Genders
Phase:
NA
Brief Summary
Intracytoplasmic sperm injection (ICSI) has successfully been used to treat both severe male infertility and fertilization failure since its introduction in the early 1990´s. During the procedure a si...
Eligibility Criteria
Inclusion
- Patients receiving controlled ovarian stimulation with gonadotrophins needing ICSI for fertilizing oocytes.
- Availability of at least six mature oocytes (MII) after oocyte pick-up.
- Planned blastocyst culture.
Exclusion
- Intention to perform any form of preimplantation genetic testing
- The use of IMSI or polarized light in the ICSI process
- The use of assisted hatching prior to randomization.
- Surgical sperm retrieval (SSR) patients.
- Previous participation in this RCT
- Concurrent participation in another investigation that can affect the primary outcome of this study.
- Sperm sample with \<0.1million/ml or motility of \<2% after preparation.
- Fertility preservation cycles.
- If a day 2-4 transfer is planned
- Use of vitrified oocytes.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
265 Patients enrolled
Trial Details
Trial ID
NCT04669652
Start Date
September 1 2023
End Date
October 1 2024
Last Update
October 27 2022
Active Locations (2)
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1
Nurture Fertility (TFP)
Nottingham, United Kingdom, NG10 5QG
2
Oxford Fertility (TFP)
Oxford, United Kingdom, OX4 2HW