Severe Male Factor Infertility Management (OAT)

B

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)

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

Trial contacts and locations

3

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Central trial contact

Salah Elbashir, M.Sc; Yasmin Magdi, M.Sc

Data sourced from clinicaltrials.gov

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