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NCT02051075 Clinical Trial

Fertilizations With Immotile Sperm: Pentoxyphylline Activation Alone, or With Chemical Oocyte Activation

Infertility Clinical Trial

— PXN  

Official title:
A Randomized Controlled Trial to Compare Fertilizations With Immotile Sperm After Pentoxyphylline Activation Alone, or With Chemical Oocyte Activation

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02051075
Other study ID # RMB 0443-13
Secondary ID 0443-13-RMB
Status Withdrawn
Phase Phase 4
First received January 29, 2014
Last updated May 5, 2015
Start date March 2014
Est. completion date May 2015

Study information
Verified date May 2015
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

Immotile sperm is a rather frequent problem encountered in IVF patients. Treatment is usually based on inducing motility with pentoxyphylline (PXN) followed by ICSI. However, fertilization rate with this method is still lower compared with ICSI using motile sperm. One of the reasons for that is the immotile sperm inability to activate the oocyte Our research hypothesis is that better fertilization rate can be accomplished in these cases by combining PXN sperm activation with Ca ionophore oocyte activation.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria:

- Women up to 35 years of age

- immotile sperm

- At least 6 mature eggs

Exclusion Criteria:

- globozoospermia

- "Freeze all" cycles because of OHSS risk.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• PXN sperm treatment
immotile sperm activation with PXN
• Sperm activation with PXN and oocyte activation

Locations
Country Name City State
Israel Rambam medical Center Haifa

Sponsors (1)
Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Clinical pregnancy Demonstration of fetal heart activity 1 month post oocyte retrieval. One month post oocyte retrieval No
Secondary Fertilization rate Normal, 2 pronuclei, zygote one day post ICSI One day post oocyte retrieval No
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