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
|Condition or disease||Intervention/treatment||Phase|
|Oligoasthenoteratozoospermia||Other: Antioxidant (l-cratinine) + modifiable lifestyle factors||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Clinical pregnancy rate [ Time Frame: two weeks ]
- Implantation rate [ Time Frame: one month ]
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
|Contact: Salah Elbashir, M.Sc||+201221371738||Dr.firstname.lastname@example.org|
|Contact: Yasmin Magdi, M.Sc||+201282313979||Yas.email@example.com|
|Dar Almaraa fertility and gynacology center||Recruiting|
|Contact: Yasmin Magdi, M.Sc|
|Elite fertility care center||Recruiting|
|Contact: Prof. Ayman Rashed, pHD +201006023284|
|Nile badrawi Hospital||Recruiting|
|Contact: Ahmed El-Damen, M.Sc|
|Study Director:||Salah Elbashir||Department of Urology, Benha university, Egypt|