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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

August 12, 2013
August 15, 2013
August 2013
August 2014   (final data collection date for primary outcome measure)
Biological pregnancy test [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01924104 on ClinicalTrials.gov Archive Site
Fetal heart/Gestational sac [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effects of Aspirin and Low Molecular Weight Heparin in IVF Outcome.
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.

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

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
To Investigate the Effects of Low Dose Aspirin and Low Molecular Weight Heparin in IVF Out Come
  • Drug: Low molecular weight heparin
    2500 mIU/day, subcutaneously
    Other Name: LMWH
  • Drug: Low dose aspirin
    75 mg/day, orally
    Other Name: Ecoaspirin
  • Drug: Heparin & aspirin
    Aspirin (70 mg/day, orally) & heparin (40 mg/day, subcutaneously)
    Other Name: LMWH & Ecoaspirin
  • Other: NaCl
    Equivalent volume of NaCl 0.9%, subcutaneously
  • Active Comparator: Low Molecular Weight Heparin
    Low molecular weight heparin, 2500 milli-International unit/day, subcutaneously
    Intervention: Drug: Low molecular weight heparin
  • Active Comparator: Low dose aspirin
    Low dose aspirin, 75mg/day, orally
    Intervention: Drug: Low dose aspirin
  • Active Comparator: Heparin & Aspirin
    Heparin (40 mg/day, subcutaneously) and aspirin (70 mg/day, orally)
    Intervention: Drug: Heparin & aspirin
  • Placebo Comparator: Sodium chloride (NaCl)
    Equivalent volume of NaCl 0.9%, subcutaneously
    Intervention: Other: NaCl
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
December 2014
August 2014   (final data collection date for primary outcome measure)

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
Female
19 Years to 35 Years
No
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
India
 
NCT01924104
JJH2013
Yes
Dr.Vandana Bansal, Jeevan Jyoti Hospital
Dr.Vandana Bansal
Not Provided
Principal Investigator: Vandana Bansal, MS DGO PhD Arpit Test Tube Baby Centre, Vandana Women's Hospital, Jeevan Jyoti Hospital & Research Centre
Jeevan Jyoti Hospital
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP