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

NCT ID: NCT01924104

Last Updated: 2013-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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

Keywords

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IVF failure, implantation rate, heparin & aspirin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Low Molecular Weight Heparin

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

Group Type ACTIVE_COMPARATOR

Low molecular weight heparin

Intervention Type DRUG

2500 mIU/day, subcutaneously

Low dose aspirin

Low dose aspirin, 75mg/day, orally

Group Type ACTIVE_COMPARATOR

Low dose aspirin

Intervention Type DRUG

75 mg/day, orally

Heparin & Aspirin

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

Group Type ACTIVE_COMPARATOR

Heparin & aspirin

Intervention Type DRUG

Aspirin (70 mg/day, orally) \& heparin (40 mg/day, subcutaneously)

Sodium chloride (NaCl)

Equivalent volume of NaCl 0.9%, subcutaneously

Group Type PLACEBO_COMPARATOR

NaCl

Intervention Type OTHER

Equivalent volume of NaCl 0.9%, subcutaneously

Interventions

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Low molecular weight heparin

2500 mIU/day, subcutaneously

Intervention Type DRUG

Low dose aspirin

75 mg/day, orally

Intervention Type DRUG

Heparin & aspirin

Aspirin (70 mg/day, orally) \& heparin (40 mg/day, subcutaneously)

Intervention Type DRUG

NaCl

Equivalent volume of NaCl 0.9%, subcutaneously

Intervention Type OTHER

Other Intervention Names

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LMWH Ecoaspirin LMWH & Ecoaspirin

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dr.Vandana Bansal

OTHER

Sponsor Role lead

Responsible Party

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Dr.Vandana Bansal

Director & Consultant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Vandana Bansal, MS DGO PhD

Role: PRINCIPAL_INVESTIGATOR

Arpit Test Tube Baby Centre, Vandana Women's Hospital, Jeevan Jyoti Hospital & Research Centre

Locations

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Arpit Test Tube Baby Centre, Jeevan Jyoti Hospital & Research Centre

Allahābād, Uttar Pradesh, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Vandana Bansal, MS DGO PhD

Role: CONTACT

Phone: +91-0532-2417252

Email: [email protected]

Ashwani K Bansal, MS

Role: CONTACT

Phone: +91-0532-2417252

Email: [email protected]

Facility Contacts

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Vandana Bansal, MS DGO PhD

Role: primary

Ashwani K Bansal, MS

Role: backup

Other Identifiers

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JJH2013

Identifier Type: -

Identifier Source: org_study_id