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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Jeevan Jyoti Hospital
Sponsor:
Information provided by (Responsible Party):
Dr.Vandana Bansal, Jeevan Jyoti Hospital
ClinicalTrials.gov Identifier:
NCT01924104
First received: August 12, 2013
Last updated: August 15, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
To Investigate the Effects of Low Dose Aspirin and Low Molecular Weight Heparin in IVF Out Come
Drug: Low molecular weight heparin
Drug: Low dose aspirin
Drug: Heparin & aspirin
Other: NaCl
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Jeevan Jyoti Hospital:

Primary Outcome Measures:
  • Biological pregnancy test [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Fetal heart/Gestational sac [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: August 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: LMWH
Active Comparator: Low dose aspirin
Low dose aspirin, 75mg/day, orally
Drug: Low dose aspirin
75 mg/day, orally
Other Name: 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 Name: LMWH & Ecoaspirin
Placebo Comparator: Sodium chloride (NaCl)
Equivalent volume of NaCl 0.9%, subcutaneously
Other: NaCl
Equivalent volume of NaCl 0.9%, subcutaneously

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   19 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01924104

Contacts
Contact: Vandana Bansal, MS DGO PhD +91-0532-2417252 ext 402 bansal.drvandana@gmail.com
Contact: Ashwani K Bansal, MS +91-0532-2417252 ext 403 arpitivf@gmail.com

Locations
India
Arpit Test Tube Baby Centre, Jeevan Jyoti Hospital & Research Centre Recruiting
Allahabad, Uttar Pradesh, India, 211003
Contact: Vandana Bansal, MS DGO PhD    +91-0532-2417252 ext 402    bansal.drvandana@gmail.com   
Contact: Ashwani K Bansal, MS    +91-0532-2417252 ext 403    arpitivf@gmail.com   
Principal Investigator: Vandana Bansal, MS DGO PhD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Dr.Vandana Bansal, Director & Consultant, Jeevan Jyoti Hospital
ClinicalTrials.gov Identifier: NCT01924104     History of Changes
Other Study ID Numbers: JJH2013
Study First Received: August 12, 2013
Last Updated: August 15, 2013
Health Authority: India: Institutional Review Board

Keywords provided by Jeevan Jyoti Hospital:
IVF failure, implantation rate, heparin & aspirin

Additional relevant MeSH terms:
Aspirin
Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Anticoagulants

ClinicalTrials.gov processed this record on July 31, 2014