Back to resultsEffects of Aspirin and Low Molecular Weight Heparin in IVF Outcome.
Primary Purpose
To Investigate the Effects of Low Dose Aspirin and Low Molecular Weight Heparin in IVF Out Come
Status
Unknown status
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Low molecular weight heparin
Low dose aspirin
Heparin & aspirin
NaCl
Sponsored by
About this trial
This is an interventional treatment trial for To Investigate the Effects of Low Dose Aspirin and Low Molecular Weight Heparin in IVF Out Come focused on measuring IVF failure, implantation rate, heparin & aspirin
Eligibility Criteria
Inclusion Criteria:
- Aged between 19 to 35 years;
- Basal follicle-stimulating hormone (FSH) levels of ≤8 IU/l
- Body mass index (BMI) between 19 kg/m2 and 25 kg/m2
- Presence of both ovaries; ≥2 previous IVF failures
- Good quality embryos for transfer
- Endometrial thickness between 10 mm and 14 mm
Exclusion Criteria:
- Polycystic ovary syndrome
- Endometriosis
Sites / Locations
- Arpit Test Tube Baby Centre, Jeevan Jyoti Hospital & Research CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Low Molecular Weight Heparin
Low dose aspirin
Heparin & Aspirin
Sodium chloride (NaCl)
Arm Description
Low molecular weight heparin, 2500 milli-International unit/day, subcutaneously
Low dose aspirin, 75mg/day, orally
Heparin (40 mg/day, subcutaneously) and aspirin (70 mg/day, orally)
Equivalent volume of NaCl 0.9%, subcutaneously
Outcomes
Primary Outcome Measures
Biological pregnancy test
Secondary Outcome Measures
Fetal heart/Gestational sac
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01924104
Brief Title
Effects of Aspirin and Low Molecular Weight Heparin in IVF Outcome.
Official Title
Effects of Low Dose Aspirin and Low Molecular Weight Heparin Cotreatment, Alone and/or in Combination on Implantation and Clinical Pregnancy Rates in Repeated Implantation Failures in IVF Cycle.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr.Vandana Bansal
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of the study is to determine whether low-dose aspirin and low molecular weight heparin improve the implantation and pregnancy rates in patients with repeated implantation failures in IVF cycle.
Detailed Description
The investigators hypothesize that cotreatment of low dose aspirin & low molecular weight heparin may improve implantation & clinical pregnancy rates.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
To Investigate the Effects of Low Dose Aspirin and Low Molecular Weight Heparin in IVF Out Come
Keywords
IVF failure, implantation rate, heparin & aspirin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low Molecular Weight Heparin
Arm Type
Active Comparator
Arm Description
Low molecular weight heparin, 2500 milli-International unit/day, subcutaneously
Arm Title
Low dose aspirin
Arm Type
Active Comparator
Arm Description
Low dose aspirin, 75mg/day, orally
Arm Title
Heparin & Aspirin
Arm Type
Active Comparator
Arm Description
Heparin (40 mg/day, subcutaneously) and aspirin (70 mg/day, orally)
Arm Title
Sodium chloride (NaCl)
Arm Type
Placebo Comparator
Arm Description
Equivalent volume of NaCl 0.9%, subcutaneously
Intervention Type
Drug
Intervention Name(s)
Low molecular weight heparin
Other Intervention Name(s)
LMWH
Intervention Description
2500 mIU/day, subcutaneously
Intervention Type
Drug
Intervention Name(s)
Low dose aspirin
Other Intervention Name(s)
Ecoaspirin
Intervention Description
75 mg/day, orally
Intervention Type
Drug
Intervention Name(s)
Heparin & aspirin
Other Intervention Name(s)
LMWH & Ecoaspirin
Intervention Description
Aspirin (70 mg/day, orally) & heparin (40 mg/day, subcutaneously)
Intervention Type
Other
Intervention Name(s)
NaCl
Intervention Description
Equivalent volume of NaCl 0.9%, subcutaneously
Primary Outcome Measure Information:
Title
Biological pregnancy test
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Fetal heart/Gestational sac
Time Frame
8 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged between 19 to 35 years;
Basal follicle-stimulating hormone (FSH) levels of ≤8 IU/l
Body mass index (BMI) between 19 kg/m2 and 25 kg/m2
Presence of both ovaries; ≥2 previous IVF failures
Good quality embryos for transfer
Endometrial thickness between 10 mm and 14 mm
Exclusion Criteria:
Polycystic ovary syndrome
Endometriosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vandana Bansal, MS DGO PhD
Phone
+91-0532-2417252
Ext
402
Email
bansal.drvandana@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ashwani K Bansal, MS
Phone
+91-0532-2417252
Ext
403
Email
arpitivf@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vandana Bansal, MS DGO PhD
Organizational Affiliation
Arpit Test Tube Baby Centre, Vandana Women's Hospital, Jeevan Jyoti Hospital & Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arpit Test Tube Baby Centre, Jeevan Jyoti Hospital & Research Centre
City
Allahabad
State/Province
Uttar Pradesh
ZIP/Postal Code
211003
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vandana Bansal, MS DGO PhD
Phone
+91-0532-2417252
Ext
402
Email
bansal.drvandana@gmail.com
First Name & Middle Initial & Last Name & Degree
Ashwani K Bansal, MS
Phone
+91-0532-2417252
Ext
403
Email
arpitivf@gmail.com
First Name & Middle Initial & Last Name & Degree
Vandana Bansal, MS DGO PhD
12. IPD Sharing Statement
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Effects of Aspirin and Low Molecular Weight Heparin in IVF Outcome.
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