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

D

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

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

Trial contacts and locations

1

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Central trial contact

Vandana Bansal, MS DGO PhD; Ashwani K Bansal, MS

Data sourced from clinicaltrials.gov

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