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Low-Dose Aspirin in in Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) Treatments

Primary Purpose

Pregnancy, Miscarriage Less Than 12 Gestational Weeks, Extrauterine Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Acetylsalicylic acid
Placebo
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pregnancy focused on measuring Assisted reproduction, Ovarian response, Uteroplacental hemodynamics, Doppler ultrasonography, Implantation rate, Pregnancy rate, Live birth rate

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • age < 40 years
  • < 4 previous ovarian stimulations

Exclusion Criteria:

  • allergy for acetylsalicylic acid

Sites / Locations

  • University Hospital of Oulu, Department of Obstetrics and Gynecology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Acetylsalicylic acid 100 mg daily perorally

Placebo daily perorally

Outcomes

Primary Outcome Measures

Pregnancy rate

Secondary Outcome Measures

Uterine artery and spiral artery pulsatility index values

Full Information

First Posted
May 21, 2008
Last Updated
May 22, 2008
Sponsor
University of Oulu
Collaborators
Bayer, Kuopio University Hospital, Tampere University
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1. Study Identification

Unique Protocol Identification Number
NCT00683202
Brief Title
Low-Dose Aspirin in in Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) Treatments
Official Title
The Significance of Low-Dose Aspirin on Ovarian Responsiveness, Uterine Hemodynamics and Pregnancy Outcome in in Vitro Fertilization and in Intracytoplasmic Sperm Injection: A Randomized, Placebo-Controlled Double-Blind Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2001
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Oulu
Collaborators
Bayer, Kuopio University Hospital, Tampere University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this study we hypothesized that low-dose aspirin therapy (100 mg daily) improves ovarian responsiveness, uterine haemodynamics and clinical pregnancy rates in unselected subjects undergoing IVF/ICSI when the treatment is started concomitantly with controlled ovarian hyperstimulation.
Detailed Description
Low-dose acetylsalicylic acid irreversibly inhibits the cyclo-oxygenase enzyme in platelets, thus preventing the synthesis of thromboxane, which causes vasoconstriction and platelet aggregation. By this mechanism low-dose aspirin may enhance ovarian and uterine blood flow and tissue perfusion and thus improve ovarian responsiveness for gonadotrophins and endometrial receptivity for implantation. Randomized controlled studies and meta-analyses on the low-dose aspirin therapy to improve IVF/ICSI outcome or uterine hemodynamics have revealed conflicting results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Miscarriage Less Than 12 Gestational Weeks, Extrauterine Pregnancy, Preeclampsia, Intrauterine Fetal Growth Restriction
Keywords
Assisted reproduction, Ovarian response, Uteroplacental hemodynamics, Doppler ultrasonography, Implantation rate, Pregnancy rate, Live birth rate

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
374 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Acetylsalicylic acid 100 mg daily perorally
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo daily perorally
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic acid
Other Intervention Name(s)
Low-dose aspirin
Intervention Description
Acetylsalicylic acid 100 mg or placebo daily perorally started on the first day of ovarian gonadotrophin stimulation in in vitro fertilization or in intracytoplasmic sperm injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Acetylsalicylic acid 100 mg or placebo daily perorally started on the first day of ovarian gonadotrophin stimulation in in vitro fertilization or in intracytoplasmic sperm injection
Primary Outcome Measure Information:
Title
Pregnancy rate
Time Frame
Five weeks after embryo transfer
Secondary Outcome Measure Information:
Title
Uterine artery and spiral artery pulsatility index values
Time Frame
On the day of embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age < 40 years < 4 previous ovarian stimulations Exclusion Criteria: allergy for acetylsalicylic acid
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mervi Haapsamo, MD
Organizational Affiliation
University Hospital of Oulu, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juha Rasanen, MD
Organizational Affiliation
University Hospital of Oulu, Finland and Oregon Health Sciences University, Oregon USA
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Hannu Martikainen, MD
Organizational Affiliation
University Hospital of Oulu, Finland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Juha S Tapanainen, Prof
Organizational Affiliation
University Hospital of Oulu, Finland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Seppo Heinonen, Prof
Organizational Affiliation
University Hospital of Kuopio, Finland
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Helena Tinkanen, MD
Organizational Affiliation
Unversity Hospital of Tampere, Finland
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital of Oulu, Department of Obstetrics and Gynecology
City
Oulu
ZIP/Postal Code
90220
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
20943705
Citation
Haapsamo M, Martikainen H, Tinkanen H, Heinonen S, Nuojua-Huttunen S, Rasanen J. Low-dose aspirin therapy and hypertensive pregnancy complications in unselected IVF and ICSI patients: a randomized, placebo-controlled, double-blind study. Hum Reprod. 2010 Dec;25(12):2972-7. doi: 10.1093/humrep/deq286. Epub 2010 Oct 13.
Results Reference
derived
PubMed Identifier
19153091
Citation
Haapsamo M, Martikainen H, Rasanen J. Low-dose aspirin and uterine haemodynamics on the day of embryo transfer in women undergoing IVF/ICSI: a randomized, placebo-controlled, double-blind study. Hum Reprod. 2009 Apr;24(4):861-6. doi: 10.1093/humrep/den489. Epub 2009 Jan 18.
Results Reference
derived

Learn more about this trial

Low-Dose Aspirin in in Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) Treatments

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