Effects of Aspirin and Low Molecular Weight Heparin in IVF Outcome.

August 15, 2013 updated by: Dr.Vandana Bansal

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The investigators hypothesize that cotreatment of low dose aspirin & low molecular weight heparin may improve implantation & clinical pregnancy rates.

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • India
    • Uttar Pradesh
      • Allahabad, Uttar Pradesh, India, 211003
        • Recruiting
        • Arpit Test Tube Baby Centre, Jeevan Jyoti Hospital & Research Centre
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vandana Bansal, MS DGO PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low Molecular Weight Heparin
Low molecular weight heparin, 2500 milli-International unit/day, subcutaneously
Drug: Low molecular weight heparin
2500 mIU/day, subcutaneously
Other Names:
  • LMWH
Active Comparator: Low dose aspirin
Low dose aspirin, 75mg/day, orally
Drug: Low dose aspirin
75 mg/day, orally
Other Names:
  • Ecoaspirin
Active Comparator: Heparin & Aspirin
Heparin (40 mg/day, subcutaneously) and aspirin (70 mg/day, orally)
Drug: Heparin & aspirin
Aspirin (70 mg/day, orally) & heparin (40 mg/day, subcutaneously)
Other Names:
  • LMWH & Ecoaspirin
Placebo Comparator: Sodium chloride (NaCl)
Equivalent volume of NaCl 0.9%, subcutaneously
Other: NaCl
Equivalent volume of NaCl 0.9%, subcutaneously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Biological pregnancy test
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Fetal heart/Gestational sac
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr.Vandana Bansal

Investigators

  • Principal Investigator: Vandana Bansal, MS DGO PhD, Arpit Test Tube Baby Centre, Vandana Women's Hospital, Jeevan Jyoti Hospital & Research Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

August 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

August 12, 2013

First Submitted That Met QC Criteria

August 15, 2013

First Posted (Estimate)

August 16, 2013

Study Record Updates

Last Update Posted (Estimate)

August 16, 2013

Last Update Submitted That Met QC Criteria

August 15, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JJH2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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