Severe Male Factor Infertility Management (OAT)

Benha University

Status: Unknown

Conditions: Oligoasthenoteratozoospermia

Treatments: Other: Antioxidant (l-cratinine) + modifiable lifestyle factors

Study type: Interventional

Funder types: Other

Identifiers

NCT02752555

00287597

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 20 to 39 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Antioxidant group

No Intervention group

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).

Antioxidant+modifiable lifestyle factors

Experimental group

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.

Treatment:

Other: Antioxidant (l-cratinine) + modifiable lifestyle factors