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

Dr.Vandana Bansal

Status and phase: Unknown; Phase 3

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

Treatments: Other: NaCl; Drug: Heparin & aspirin; Drug: Low molecular weight heparin; Drug: Low dose aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT01924104

JJH2013

Details and patient eligibility

About

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.

Full description

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

Enrollment: 400 estimated patients

Sex: Female

Ages: 19 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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400 participants in 4 patient groups, including a placebo group

Low Molecular Weight Heparin

Active Comparator group

Description:

Low molecular weight heparin, 2500 milli-International unit/day, subcutaneously

Treatment:

Drug: Low molecular weight heparin

Low dose aspirin

Active Comparator group

Description:

Low dose aspirin, 75mg/day, orally

Treatment:

Drug: Low dose aspirin

Heparin & Aspirin

Active Comparator group

Description:

Heparin (40 mg/day, subcutaneously) and aspirin (70 mg/day, orally)

Treatment:

Drug: Heparin & aspirin

Sodium chloride (NaCl)

Placebo Comparator group

Description:

Equivalent volume of NaCl 0.9%, subcutaneously

Treatment:

Other: NaCl