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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Endometritis
• Intervention / Treatment: Drug: Dead Sea Peloid Gel

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Irkutsk, Russian Federation, 664003
    • Scientific Center for Family Health and Human Reproduction Problems

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The prevalence of spontaneous pregnancy the first year after treatment	during first year

Secondary Outcome Measures

Outcome Measure	Time Frame
The prevalence of women with morphological status of chronic endometritis by the 3 months after treatment.	during 3 months

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: December 22, 2015
• First Submitted That Met QC Criteria: February 10, 2016
• First Posted (Estimate): February 11, 2016

Study Record Updates

• Last Update Posted (Estimate): February 11, 2016
• Last Update Submitted That Met QC Criteria: February 10, 2016
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Infertility; Miscarriage; Chronic endometritis
• Additional Relevant MeSH Terms: Uterine Diseases; Adnexal Diseases; Pelvic Inflammatory Disease; Endometritis
• Other Study ID Numbers: 16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD 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.