Severe Male Factor Infertility Management

Oligoasthenoteratozoospermia Clinical Trial

— OAT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02752555
• Other study ID #: 00287597
• Status: Recruiting
• Phase: N/A
• First received: April 23, 2016
• Last updated: November 25, 2016
• Start date: April 2016

Study information

• Verified date: November 2016
• Source: Benha University
• Contact: Salah Elbashir, M.Sc
• Phone: +201221371738
• Email: Dr.salah.elbashir[@]gmail.com
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 39 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Oligoasthenoteratozoospermia

Intervention

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.

Locations

Country	Name	City	State
Egypt	Dar Almaraa fertility and gynacology center	Cairo
Egypt	Elite fertility care center	Cairo
Egypt	Nile badrawi Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical pregnancy rate		two weeks	Yes
Primary	Implantation rate		one month	Yes