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Efficacy of Dead Sea Peloid Gel in Chronic Endometritis

Primary Purpose

Chronic Endometritis

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Dead Sea Peloid Gel
Sponsored by
Scientific Center for Family Health and Human Reproduction Problems, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Endometritis focused on measuring Chronic endometritis, Miscarriage, Infertility

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Scientific Center for Family Health and Human Reproduction Problems

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Doxycycline,Dead Sea Peloid Gel,placebo

Arm Description

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

Outcomes

Primary Outcome Measures

The prevalence of spontaneous pregnancy the first year after treatment

Secondary Outcome Measures

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

Full Information

First Posted
December 22, 2015
Last Updated
February 10, 2016
Sponsor
Scientific Center for Family Health and Human Reproduction Problems, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT02680275
Brief Title
Efficacy of Dead Sea Peloid Gel in Chronic Endometritis
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 Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Scientific Center for Family Health and Human Reproduction Problems, Russia

4. Oversight

Data Monitoring Committee
Yes

5. 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.
Detailed Description
Dead Sea Peloid Gel achieves improvement of blood circulation and receptor sensitivity of endometrium.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Endometritis
Keywords
Chronic endometritis, Miscarriage, Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Doxycycline,Dead Sea Peloid Gel,placebo
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Dead Sea Peloid Gel
Other Intervention Name(s)
Placebo Gel
Intervention Description
intravaginally
Primary Outcome Measure Information:
Title
The prevalence of spontaneous pregnancy the first year after treatment
Time Frame
during first year
Secondary Outcome Measure Information:
Title
The prevalence of women with morphological status of chronic endometritis by the 3 months after treatment.
Time Frame
during 3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina A Darenskaya, MD
Organizational Affiliation
Scientific Center for Family Health and Human Reproduction Problems
Official's Role
Study Chair
Facility Information:
Facility Name
Scientific Center for Family Health and Human Reproduction Problems
City
Irkutsk
ZIP/Postal Code
664003
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The study can generate the publications related to the outcomes. The investigator initiating the protocol (Protocol leader/coPI) will be the first (primary) author of the publication. The publication wil also could involve the names of the site investigators who have contributed to the study. The authorship order of the site investigators will be based upon personal contribution to the study, approved by the SCFHHRP (sponsor). The primary affiliation of the study is SCFHHRP.

Learn more about this trial

Efficacy of Dead Sea Peloid Gel in Chronic Endometritis

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