Back to resultsHabitual Abortion Study: Oral Dydrogesterone Treatment During Pregnancy in Women With Recurrent Miscarriage
Primary Purpose
Recurrent Miscarriage
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dydrogesterone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Miscarriage focused on measuring Pregnancy, Immunology, Unexplained recurrent miscarriage
Eligibility Criteria
Inclusion Criteria Women with a history of idiopathic recurrent miscarriage, based on a documented history of at least three spontaneous consecutive miscarriages before 20 weeks gestation with the same partner Exclusion Criteria Any verifiable cause of the recurrent miscarriages apart from luteal phase defect (e.g. systemic lupus erythematosus [SLE], infections with chlamydia or mycoplasma) Any gynecological neoplasias or anatomical abnormalities that oppose pregnancy Concurrent infertility treatment/superovulation protocol
Sites / Locations
- Site Reference ID/Investigator# 61182
- Site Reference ID/Investigator# 61183
- Site Reference ID/Investigator# 61184
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Cytokine ratio IFN/IL-10
Secondary Outcome Measures
Exploratory analysis of pregnancy outcome by monitoring biochemical and clinical pregnancy parameters, weekly evaluation of serum progesterone
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00193674
Brief Title
Habitual Abortion Study: Oral Dydrogesterone Treatment During Pregnancy in Women With Recurrent Miscarriage
Official Title
Oral Dydrogesterone Treatment During the First Trimester of Pregnancy in Women With Recurrent Miscarriage: A Double-Blind, Prospectively Randomized, Placebo-Controlled, Parallel Group Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Products
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this clinical study is to demonstrate the shift from inflammatory cytokines to non-inflammatory cytokines in women suffering from habitual abortion treated with dydrogesterone (Duphaston).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Miscarriage
Keywords
Pregnancy, Immunology, Unexplained recurrent miscarriage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dydrogesterone
Intervention Description
20 mg/day, oral
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Cytokine ratio IFN/IL-10
Time Frame
14 weeks treatment after diagnosed pregnancy (week of gestation 4 to 18)
Secondary Outcome Measure Information:
Title
Exploratory analysis of pregnancy outcome by monitoring biochemical and clinical pregnancy parameters, weekly evaluation of serum progesterone
Time Frame
First trimester of pregnancy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Women with a history of idiopathic recurrent miscarriage, based on a documented history of at least three spontaneous consecutive miscarriages before 20 weeks gestation with the same partner Exclusion Criteria
Any verifiable cause of the recurrent miscarriages apart from luteal phase defect (e.g. systemic lupus erythematosus [SLE], infections with chlamydia or mycoplasma)
Any gynecological neoplasias or anatomical abnormalities that oppose pregnancy
Concurrent infertility treatment/superovulation protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guenter Krause, MD
Organizational Affiliation
Abbott Products
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 61182
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Site Reference ID/Investigator# 61183
City
Poznan
ZIP/Postal Code
60-535
Country
Poland
Facility Name
Site Reference ID/Investigator# 61184
City
Szczecin
ZIP/Postal Code
72-010
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Habitual Abortion Study: Oral Dydrogesterone Treatment During Pregnancy in Women With Recurrent Miscarriage
We'll reach out to this number within 24 hrs