Back to resultsSevere Male Factor Infertility Management (OAT)
Primary Purpose
Oligoasthenoteratozoospermia
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Antioxidant (l-cratinine) + modifiable lifestyle factors
Sponsored by
About this trial
This is an interventional treatment trial for Oligoasthenoteratozoospermia focused on measuring Oligoasthenoteratozoospermia, Male factor managment, Intacytoplasmic sperm injection
Eligibility 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
Sites / Locations
- Dar Almaraa fertility and gynacology centerRecruiting
- Elite fertility care centerRecruiting
- Nile badrawi HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Antioxidant group
Antioxidant+modifiable lifestyle factors
Arm Description
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).
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.
Outcomes
Primary Outcome Measures
Clinical pregnancy rate
Implantation rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02752555
Brief Title
Severe Male Factor Infertility Management
Acronym
OAT
Official Title
Investigating the Effect of Modifiable Lifestyle Factors in Severe Oligoasthenotertozoospermic Men Combined With Antioxidant Treatment Prior ICSI
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oligoasthenoteratozoospermia
Keywords
Oligoasthenoteratozoospermia, Male factor managment, Intacytoplasmic sperm injection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Antioxidant group
Arm Type
No Intervention
Arm Description
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).
Arm Title
Antioxidant+modifiable lifestyle factors
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Antioxidant (l-cratinine) + modifiable lifestyle factors
Intervention Description
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 Measure Information:
Title
Clinical pregnancy rate
Time Frame
two weeks
Title
Implantation rate
Time Frame
one month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Salah Elbashir, M.Sc
Phone
+201221371738
Email
Dr.salah.elbashir@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yasmin Magdi, M.Sc
Phone
+201282313979
Email
Yas.magdi@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salah Elbashir
Organizational Affiliation
Department of Urology, Benha university, Egypt
Official's Role
Study Director
Facility Information:
Facility Name
Dar Almaraa fertility and gynacology center
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yasmin Magdi, M.Sc
Facility Name
Elite fertility care center
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Ayman Rashed, pHD
Phone
+201006023284
Facility Name
Nile badrawi Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed El-Damen, M.Sc
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Publishing a manuscript
Citations:
PubMed Identifier
17550489
Citation
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.
Results Reference
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Severe Male Factor Infertility Management
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