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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by Dr.Vandana Bansal, Jeevan Jyoti Hospital.
Recruitment status was:  Recruiting
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 ]
Same as current
No Changes Posted
Fetal heart/Gestational sac [ Time Frame: 8 weeks ]
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
Intervention Model: Factorial Assignment
Masking: Single Blind (Participant)
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.
 
Unknown status
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
Sexes Eligible for Study: Female
19 Years to 35 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01924104
JJH2013
Yes
Not Provided
Not Provided
Not Provided
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