Efficacy of Dead Sea Peloid Gel in Chronic Endometritis | NCT02680275

Studies
Efficacy of Dead Sea Peloid Gel in Chronic Endometritis

NCT02680275

Sponsor

Scientific Center for Family Health and Human Reproduction Problems, Russia

Status

Completed

Last Update Posted

Feb 11, 2016Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Chronic Endometritis

Interventions

Dead Sea Peloid Gel

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2011

Primary Completion Date

Jun 2013Actual

Completion Date

Jun 2013Actual

First Submitted Date

Dec 22, 2015

First Submission Date that Met QC Criteria

Feb 10, 2016

First Posted Date

Feb 11, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2016

Last Update Posted Date

Feb 11, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Irina N. Danusevich, Principal Investigator, Scientific Center for Family Health and Human Reproduction Problems, RussiaPrincipal Investigator

Lead Sponsor

Scientific Center for Family Health and Human Reproduction Problems, RussiaOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Doxycycline,Dead Sea Peloid Gel,placebo	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dead Sea Peloid Gel	Drug	intravaginally	Doxycycline,Dead Sea Peloid Gel,placebo

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marina A Darenskaya, MD	Scientific Center for Family Health and Human Reproduction Problems	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Scientific Center for Family Health and Human Reproduction Problems		Irkutsk		664003	Russia

IPD Sharing Statement Module

Plan to Share IPD

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000022	Abortion, Spontaneous
D007246	Infertility

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D000091662	Genital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided