Spermotrend in the Treatment of Male Infertility

NCT ID: NCT00975117

Last Updated: 2011-03-08

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-03-31

Brief Summary

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The purpose of this study is to determine whether the administration of the dietary supplement Spermotrend improves spermatogenesis parameters in subjects with male infertility unrelated to major testicular conditions. The duration of this double-blind placebo controlled phase 3 clinical trial will be 24 weeks. The estimated number of males with infertility to be recruited and randomized for the study is 86.

Detailed Description

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Conditions

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Male Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

One Placebo tablet (Orally administered) twice a day, for 12 weeks.

Spermotrend

Group Type EXPERIMENTAL

Spermotrend

Intervention Type DIETARY_SUPPLEMENT

One Spermotrend tablet (Orally administered) twice a day, for 12 weeks

Interventions

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Placebo

One Placebo tablet (Orally administered) twice a day, for 12 weeks.

Intervention Type DIETARY_SUPPLEMENT

Spermotrend

One Spermotrend tablet (Orally administered) twice a day, for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Male infertility unrelated to major testicular conditions
* Must have at least one altered seminal parameter.
* Signed informed consent

Exclusion Criteria

* Hydrocele, varicocele, orchitis, epididymitis, irradiation or Chemotherapy.
* Previously treated and cured testicular condition.
* Non-transmissible chronic diseases
* Use of antioxidant agents within 6 months.
* Use of vitamins within 6 months.
* Use of anti-inflammatory drugs within 6 months.
* Use of hormones prescribed by an andrologist within 6 months
* Positive serology/HIV
* Leukocytospermia
Minimum Eligible Age

19 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Catalysis SL

INDUSTRY

Sponsor Role lead

Responsible Party

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"Ramón González Coro" Gynecologic and Obstetric Hospital

Principal Investigators

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Miguel Aguilar Charara, MD

Role: PRINCIPAL_INVESTIGATOR

"Ramón González Coro" Gynecologic and Obstetric Hospital

Locations

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"Ramón González Coro" Gynecologic and Obstetric Hospital

Havana, La Habana, Cuba

Site Status

Countries

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Cuba

References

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de Ligny W, Smits RM, Mackenzie-Proctor R, Jordan V, Fleischer K, de Bruin JP, Showell MG. Antioxidants for male subfertility. Cochrane Database Syst Rev. 2022 May 4;5(5):CD007411. doi: 10.1002/14651858.CD007411.pub5.

Reference Type DERIVED
PMID: 35506389 (View on PubMed)

Other Identifiers

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CAT-0905-CU

Identifier Type: -

Identifier Source: org_study_id

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