Efficacy of Dead Sea Peloid Gel in Chronic Endometritis
Efficacy of Intravaginal Dead Sea Peloid Gel Administration in Complex Treatment of Chronic Endometritis and Reproductive Disorders: Randomized Placebo-controlled Prospective Study
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 22, 2015
CompletedFirst Posted
Study publicly available on registry
February 11, 2016
CompletedFebruary 11, 2016
September 1, 2015
1.9 years
December 22, 2015
February 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The prevalence of spontaneous pregnancy the first year after treatment
during first year
Secondary Outcomes (1)
The prevalence of women with morphological status of chronic endometritis by the 3 months after treatment.
during 3 months
Study Arms (1)
Doxycycline,Dead Sea Peloid Gel,placebo
EXPERIMENTAL1. 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 2. Group -1 stage: Doxycycline 100mg 2 times per day 10 days; followed by placebo gel, 60 ml per day fo 12 days, intravaginally
Interventions
intravaginally
Eligibility Criteria
You may qualify if:
- Women with miscarriage associated with chronic endometritis
- Women without mental disorders able to swallow tablets
You may not qualify if:
- sexually transmitted diseases
- endometrium hyperplasia and/or polyps
- uterina fibroids
- endocrine disorders
- trombophilia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Scientific Center for Family Health and Human Reproduction Problems
Irkutsk, 664003, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Marina A Darenskaya, MD
Scientific Center for Family Health and Human Reproduction Problems
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 22, 2015
First Posted
February 11, 2016
Study Start
July 1, 2011
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
February 11, 2016
Record last verified: 2015-09
Data Sharing
- IPD Sharing
- Will not share
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.