Severe Male Factor Infertility Management

NCT ID: NCT02752555

Last Updated: 2016-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

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.

Conditions

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Oligoasthenoteratozoospermia

Keywords

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Oligoasthenoteratozoospermia Male factor managment Intacytoplasmic sperm injection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Antioxidant (l-cratinine) + modifiable lifestyle factors

Intervention Type OTHER

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.

Interventions

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Antioxidant (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.

Intervention Type OTHER

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Salah Elbashir

Assisting lecturer of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Salah Elbashir

Role: STUDY_DIRECTOR

Department of Urology, Benha university, Egypt

Locations

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Dar Almaraa fertility and gynacology center

Cairo, , Egypt

Site Status RECRUITING

Elite fertility care center

Cairo, , Egypt

Site Status RECRUITING

Nile badrawi Hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Salah Elbashir, M.Sc

Role: CONTACT

Phone: +201221371738

Email: [email protected]

Yasmin Magdi, M.Sc

Role: CONTACT

Phone: +201282313979

Email: [email protected]

Facility Contacts

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Yasmin Magdi, M.Sc

Role: primary

Prof. Ayman Rashed, pHD

Role: primary

Ahmed El-Damen, M.Sc

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 17550489 (View on PubMed)

Other Identifiers

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00287597

Identifier Type: -

Identifier Source: org_study_id