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Clinical Trials/NCT02752555
NCT02752555UnknownNot Applicable

Investigating the Effect of Modifiable Lifestyle Factors in Severe Oligoasthenotertozoospermic Men Combined With Antioxidant Treatment Prior ICSI

Benha University3 sites in 1 country60 target enrollmentStarted: April 2016Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
60
Locations
3
Primary Endpoint
Implantation rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

This study is the first to evaluate the effect of oral supplementation with antioxidants combined with lifestyle modification for severe male factor partner of couples undergoing ICSI.

Detailed Description

Patients underwent a therapy of a three-month period of treatment with either oral L-carnitine only (2g daily) or oral carnitine (2g daily) combined with modifiable lifestyle factors.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 39 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Long protocol for ovulation
  • •Oligoasthenoteratozoospermic male partner ( (count < 0.5 million/ml, Motility=< 40% Progressive motility =<10 %, Abnormal forms >99%).
  • •Fresh semen samples.

Exclusion Criteria

  • •Day 3 embryo transfer
  • •Incomplete ICSI cycles
  • •Endometrial thickness> 7mm

Outcomes

Primary Outcomes

Implantation rate

Time Frame: one month

Clinical pregnancy rate

Time Frame: two weeks

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Salah Elbashir

Assisting lecturer of Urology

Benha University

Study Sites (3)

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