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

NCT ID: NCT00683202

Last Updated: 2008-05-23

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

COMPLETED

Clinical Phase

NA

Total Enrollment

374 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2006-03-31

Brief Summary

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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

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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.

Conditions

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Pregnancy Miscarriage Less Than 12 Gestational Weeks Extrauterine Pregnancy Preeclampsia Intrauterine Fetal Growth Restriction

Keywords

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Assisted reproduction Ovarian response Uteroplacental hemodynamics Doppler ultrasonography Implantation rate Pregnancy rate Live birth rate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Acetylsalicylic acid 100 mg daily perorally

Group Type ACTIVE_COMPARATOR

Acetylsalicylic acid

Intervention Type DRUG

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

2

Placebo daily perorally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Acetylsalicylic acid

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

Placebo

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

Other Intervention Names

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Low-dose aspirin

Eligibility Criteria

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Inclusion Criteria

* age \< 40 years
* \< 4 previous ovarian stimulations

Exclusion Criteria

* allergy for acetylsalicylic acid
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role collaborator

Kuopio University Hospital

OTHER

Sponsor Role collaborator

Tampere University

OTHER

Sponsor Role collaborator

University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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University Hospital of Oulu

Principal Investigators

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Mervi Haapsamo, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Oulu, Finland

Juha Rasanen, MD

Role: STUDY_DIRECTOR

University Hospital of Oulu, Finland and Oregon Health Sciences University, Oregon USA

Hannu Martikainen, MD

Role: STUDY_DIRECTOR

University Hospital of Oulu, Finland

Juha S Tapanainen, Prof

Role: STUDY_DIRECTOR

University Hospital of Oulu, Finland

Seppo Heinonen, Prof

Role: STUDY_DIRECTOR

University Hospital of Kuopio, Finland

Helena Tinkanen, MD

Role: STUDY_DIRECTOR

Unversity Hospital of Tampere, Finland

Locations

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University Hospital of Oulu, Department of Obstetrics and Gynecology

Oulu, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 20943705 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19153091 (View on PubMed)

Other Identifiers

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56/2001

Identifier Type: -

Identifier Source: org_study_id