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Severe Male Factor Infertility Management (OAT)

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ClinicalTrials.gov Identifier: NCT02752555
Recruitment Status : Unknown
Verified November 2016 by Salah Elbashir, Benha University.
Recruitment status was:  Recruiting
First Posted : April 27, 2016
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):
Salah Elbashir, Benha University

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.

Condition or disease Intervention/treatment Phase
Oligoasthenoteratozoospermia Other: Antioxidant (l-cratinine) + modifiable lifestyle factors Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigating the Effect of Modifiable Lifestyle Factors in Severe Oligoasthenotertozoospermic Men Combined With Antioxidant Treatment Prior ICSI
Study Start Date : April 2016
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antioxidants

Arm Intervention/treatment
No Intervention: Antioxidant group
In 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).
Experimental: Antioxidant+modifiable lifestyle factors
In 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.
Other: Antioxidant (l-cratinine) + modifiable lifestyle factors
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.




Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: two weeks ]
  2. Implantation rate [ Time Frame: one month ]


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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02752555


Contacts
Contact: Salah Elbashir, M.Sc +201221371738 Dr.salah.elbashir@gmail.com
Contact: Yasmin Magdi, M.Sc +201282313979 Yas.magdi@hotmail.com

Locations
Egypt
Dar Almaraa fertility and gynacology center Recruiting
Cairo, Egypt
Contact: Yasmin Magdi, M.Sc         
Elite fertility care center Recruiting
Cairo, Egypt
Contact: Prof. Ayman Rashed, pHD    +201006023284      
Nile badrawi Hospital Recruiting
Cairo, Egypt
Contact: Ahmed El-Damen, M.Sc         
Sponsors and Collaborators
Benha University
Investigators
Study Director: Salah Elbashir Department of Urology, Benha university, Egypt

Publications:
Responsible Party: Salah Elbashir, Assisting lecturer of Urology, Benha University
ClinicalTrials.gov Identifier: NCT02752555     History of Changes
Other Study ID Numbers: 00287597
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Publishing a manuscript

Keywords provided by Salah Elbashir, Benha University:
Oligoasthenoteratozoospermia
Male factor managment
Intacytoplasmic sperm injection

Additional relevant MeSH terms:
Oligospermia
Infertility, Male
Infertility
Genital Diseases, Male
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs