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

To Investigate the Effects of Low Dose Aspirin and Low Molecular Weight Heparin in IVF Out Come Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01924104
• Other study ID #: JJH2013
• Status: Recruiting
• Phase: Phase 3
• First received: August 12, 2013
• Last updated: August 15, 2013
• Start date: August 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2013
• Source: Jeevan Jyoti Hospital
• Contact: Vandana Bansal, MS DGO PhD
• Phone: +91-0532-2417252
• Email: bansal.drvandana[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 35 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• To Investigate the Effects of Low Dose Aspirin and Low Molecular Weight Heparin in IVF Out Come

Intervention

Drug:
• Low molecular weight heparin
2500 mIU/day, subcutaneously
• Low dose aspirin
75 mg/day, orally
• Heparin & aspirin
Aspirin (70 mg/day, orally) & heparin (40 mg/day, subcutaneously)

Other:
• NaCl
Equivalent volume of NaCl 0.9%, subcutaneously

Locations

Country	Name	City	State
India	Arpit Test Tube Baby Centre, Jeevan Jyoti Hospital & Research Centre	Allahabad	Uttar Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Dr.Vandana Bansal

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biological pregnancy test		14 days	Yes
Secondary	Fetal heart/Gestational sac		8 weeks	Yes