ClinicalTrials.gg
Status unknownNCT02752555OATUpdated Nov 28, 2016

Severe Male Factor Infertility Management

An interventional study of Antioxidant (l-cratinine) + modifiable lifestyle factors in Oligoasthenoteratozoospermia, sponsored by Benha University. Status unknown at 3 sites in Egypt. Open to female participants aged 20 Years to 39 Years. Per ClinicalTrials.gov, last updated 2016-11-28.

Sponsored by Benha University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
20 Years to 39 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Oligoasthenoteratozoospermia

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Keywords

  • Oligoasthenoteratozoospermia
  • Male factor managment
  • Intacytoplasmic sperm injection
03

In context

Oligospermia

64 studies on the registry are indexed under Oligospermia; 17 are open to participants now.

This study's planned enrollment of 60 is close to the median of 65 across 46 interventional studies indexed under Oligospermia.

Browse Oligospermia studies →

Lead sponsor

Benha University is the lead sponsor of 362 studies on the registry; 66 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Day 3 embryo transfer
  • Incomplete ICSI cycles
  • Endometrial thickness> 7mm
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • No intervention
    Antioxidant group

    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

    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

Interventions

  • OtherAntioxidant (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.

06

What researchers measure

Primary outcomes

  1. Clinical pregnancy rate

    Time frame: two weeks

  2. Implantation rate

    Time frame: one month

07

Study locations

3 of 3 sites recruiting
  • Dar Almaraa fertility and gynacology center
    Cairo, Egypt
    Recruiting
    • Yasmin Magdi, M.Sc · Contact
  • Elite fertility care center
    Cairo, Egypt
    Recruiting
    • Prof. Ayman Rashed, pHD · Contact+201006023284
  • Nile badrawi Hospital
    Cairo, Egypt
    Recruiting
    • Ahmed El-Damen, M.Sc · Contact
08

References and documents

Publications

  • 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. PubMed 17550489 ↗

Individual participant data

Plan to share: Yes — Publishing a manuscript

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2016 and a primary completion of Dec 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 23, 2016
First posted
Apr 27, 2016
Start
Apr 2016
Primary completionEst.
Dec 2016
Last update
Nov 28, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02752555
Lead sponsor
Benha University
Responsible party
Salah Elbashir (Assisting lecturer of Urology, Benha University) — Principal investigator
First posted
Apr 27, 2016
Start date
Apr 2016
Primary completion
Dec 2016 (estimated)
Last update
Nov 28, 2016

Study contacts

Salah Elbashir, M.Sc
Contact
Dr.salah.elbashir@gmail.com
+201221371738
Yasmin Magdi, M.Sc
Contact
Yas.magdi@hotmail.com
+201282313979
Salah Elbashir
study director · Department of Urology, Benha university, Egypt

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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