Severe Male Factor Infertility Management

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Oligoasthenoteratozoospermia

Intervention / Treatment
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* Other: Antioxidant (l-cratinine) + modifiable lifestyle factors


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Antioxidant group<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical pregnancy rate |  | two weeks | 
| Implantation rate |  | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oligoasthenoteratozoospermia, Male factor managment, Intacytoplasmic sperm injection