Effects of Aspirin and Low Molecular Weight Heparin in IV... | NCT01924104

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

NCT01924104

Sponsor

Dr.Vandana Bansal

Status

Unknown status

Last Update Posted

Aug 16, 2013Estimated

Enrollment

400Estimated

Phase

Phase 3

Conditions

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

Interventions

Low molecular weight heparin
Low dose aspirin
Heparin & aspirin
NaCl

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2013

Primary Completion Date

Aug 2014Estimated

Completion Date

Dec 2014Estimated

First Submitted Date

Aug 12, 2013

First Submission Date that Met QC Criteria

Aug 15, 2013

First Posted Date

Aug 16, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 15, 2013

Last Update Posted Date

Aug 16, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low Molecular Weight Heparin	Active Comparator	Low molecular weight heparin, 2500 milli-International unit/day, subcutaneously	Drug: Low molecular weight heparin
Low dose aspirin	Active Comparator	Low dose aspirin, 75mg/day, orally	Drug: Low dose aspirin
Heparin & Aspirin	Active Comparator	Heparin (40 mg/day, subcutaneously) and aspirin (70 mg/day, orally)	Drug: Heparin & aspirin
Sodium chloride (NaCl)	Placebo Comparator	Equivalent volume of NaCl 0.9%, subcutaneously	Other: NaCl

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Low molecular weight heparin	Drug	2500 mIU/day, subcutaneously	Low Molecular Weight Heparin

Measure	Description	Time Frame
Biological pregnancy test		14 days

Measure	Description	Time Frame
Fetal heart/Gestational sac		8 weeks

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Vandana Bansal, MS DGO PhD	Contact	+91-0532-2417252	402	bansal.drvandana@gmail.com
Ashwani K Bansal, MS	Contact	+91-0532-2417252	403	arpitivf@gmail.com

Overall Officials

Name	Affiliation	Role
Vandana Bansal, MS DGO PhD	Arpit Test Tube Baby Centre, Vandana Women's Hospital, Jeevan Jyoti Hospital & Research Centre	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arpit Test Tube Baby Centre, Jeevan Jyoti Hospital & Research Centre	Recruiting	Allahābād	Uttar Pradesh	211003	India

Intervention Browse Module

MeSH Terms

ID	Term
D006495	Heparin, Low-Molecular-Weight
D001241	Aspirin
D006493	Heparin

Ancestor Terms

ID	Term
D006025	Glycosaminoglycans
D011134	Polysaccharides
D002241	Carbohydrates
D012459	Salicylates

Browse Leaves

Not provided

Browse Branches

Not provided