Severe Male Factor Infertility Management
OAT
Investigating the Effect of Modifiable Lifestyle Factors in Severe Oligoasthenotertozoospermic Men Combined With Antioxidant Treatment Prior ICSI
1 other identifier
interventional
60
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 23, 2016
CompletedFirst Posted
Study publicly available on registry
April 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedNovember 28, 2016
November 1, 2016
8 months
April 23, 2016
November 25, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Clinical pregnancy rate
two weeks
Implantation rate
one month
Study Arms (2)
Antioxidant group
NO INTERVENTIONIn the control group, all patients will go a double-blind therapy of a three-months period of treatment with oral carnitine (2g daily). After this period, all patients will undergo conventional intacytoplasmic sperm injection (ICSI).
Antioxidant+modifiable lifestyle factors
EXPERIMENTALIn the study group, all patients underwent a double-blind therapy of a six-month period of treatment with oral carnitine (2g daily) combined with modifiable lifestyle factors. Patients were requested to follow a healthy standard diet, avoid excessive heat exposure, avoid or minimize exposure to pollutants, and stop smoking, coffee, alcohol, and drugs uptake.After this period, all patients will undergo conventional ICSI.
Interventions
All participants were subjected to the same three-month period treatment protocol, which included 1) antioxidant treatment with L-Carnitine (2g daily); 2) frequent ejaculation every 2 days; and 3) minimizing adverse lifestyle factors.
Eligibility Criteria
You may qualify if:
- Long protocol for ovulation
- Oligoasthenoteratozoospermic male partner ( (count \< 0.5 million/ml, Motility=\< 40% Progressive motility =\<10 %, Abnormal forms \>99%).
- Fresh semen samples.
You may not qualify if:
- Day 3 embryo transfer
- Incomplete ICSI cycles
- Endometrial thickness\> 7mm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benha Universitylead
Study Sites (3)
Dar Almaraa fertility and gynacology center
Cairo, Egypt
Elite fertility care center
Cairo, Egypt
Nile badrawi Hospital
Cairo, Egypt
Related Publications (1)
Tremellen K, Miari G, Froiland D, Thompson J. A randomised control trial examining the effect of an antioxidant (Menevit) on pregnancy outcome during IVF-ICSI treatment. Aust N Z J Obstet Gynaecol. 2007 Jun;47(3):216-21. doi: 10.1111/j.1479-828X.2007.00723.x.
PMID: 17550489BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Salah Elbashir
Department of Urology, Benha university, Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisting lecturer of Urology
Study Record Dates
First Submitted
April 23, 2016
First Posted
April 27, 2016
Study Start
April 1, 2016
Primary Completion
December 1, 2016
Last Updated
November 28, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
Publishing a manuscript