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Efficacy of Dead Sea Peloid Gel in Chronic Endometritis

Sponsor
Scientific Center for Family Health and Human Reproduction Problems, Russia (Other)
Overall Status
Completed
CT.gov ID
NCT02680275
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
23
Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the effect of Dead Sea Peloid Gel in the treatment of Chronic Endometritis in women with reproductive disorders. Half of participants will receive Dead Sea Peloid Gel and antibiotics, while the other half will receive Placebo Gel and antibiotics.

Patients with reproductive disorders who visited Research Medical Center of Family Health Problems and Human Reproduction were recruited.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dead Sea Peloid Gel
 N/A

Detailed Description

Dead Sea Peloid Gel achieves improvement of blood circulation and receptor sensitivity of endometrium.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy of Intravaginal Dead Sea Peloid Gel Administration in Complex Treatment of Chronic Endometritis and Reproductive Disorders: Randomized Placebo-controlled Prospective Study
Study Start Date :
Jul 1, 2011
Actual Primary Completion Date :
Jun 1, 2013
Actual Study Completion Date :
Jun 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Doxycycline,Dead Sea Peloid Gel,placebo

Group -1 stage: Doxycycline 100mg 2 times per day 10 days; followed by Dead Sea Peloid Gel , 60 ml per day fo 12 days, intravaginally Group -1 stage: Doxycycline 100mg 2 times per day 10 days; followed by placebo gel, 60 ml per day fo 12 days, intravaginally

Drug: Dead Sea Peloid Gel
intravaginally
Other Names:
  • Placebo Gel

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The prevalence of spontaneous pregnancy the first year after treatment [during first year]

    Secondary Outcome Measures

    1. The prevalence of women with morphological status of chronic endometritis by the 3 months after treatment. [during 3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Women with miscarriage associated with chronic endometritis

    • Women without mental disorders able to swallow tablets

    Exclusion Criteria: Clinical diagnosis of:

    • sexually transmitted diseases

    • endometrium hyperplasia and/or polyps

    • uterina fibroids

    • endocrine disorders

    • trombophilia

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Scientific Center for Family Health and Human Reproduction Problems Irkutsk Russian Federation 664003

    Sponsors and Collaborators

    • Scientific Center for Family Health and Human Reproduction Problems, Russia

    Investigators

    • Study Chair: Marina A Darenskaya, MD, Scientific Center for Family Health and Human Reproduction Problems

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Irina N. Danusevich, Principal Investigator, Scientific Center for Family Health and Human Reproduction Problems, Russia
    ClinicalTrials.gov Identifier:
    NCT02680275
    Other Study ID Numbers:
    • 16
    First Posted:
    Feb 11, 2016
    Last Update Posted:
    Feb 11, 2016
    Last Verified:
    Sep 1, 2015
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Irina N. Danusevich, Principal Investigator, Scientific Center for Family Health and Human Reproduction Problems, Russia
    Chronic endometritis
    Miscarriage
    Infertility
    Additional relevant MeSH terms:
    Endometritis

    Study Results

    No Results Posted as of Feb 11, 2016