NCT00683202

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
374

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Mar 2001

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2008

Completed
Last Updated

May 23, 2008

Status Verified

March 1, 2001

Enrollment Period

5 years

First QC Date

May 21, 2008

Last Update Submit

May 22, 2008

Conditions

PregnancyMiscarriage Less Than 12 Gestational WeeksExtrauterine PregnancyPreeclampsiaIntrauterine Fetal Growth Restriction

Keywords

Assisted reproductionOvarian responseUteroplacental hemodynamicsDoppler ultrasonographyImplantation ratePregnancy rateLive birth rate

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    Five weeks after embryo transfer

Secondary Outcomes (1)

  • Uterine artery and spiral artery pulsatility index values

    On the day of embryo transfer

Study Arms (2)

1

ACTIVE COMPARATOR

Acetylsalicylic acid 100 mg daily perorally

Drug: Acetylsalicylic acid

2

PLACEBO COMPARATOR

Placebo daily perorally

Drug: Placebo

Interventions

Acetylsalicylic acidDRUG

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

Also known as: Low-dose aspirin
1
PlaceboDRUG

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

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • allergy for acetylsalicylic acid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Oulu, Department of Obstetrics and Gynecology

Oulu, 90220, Finland

Location

Related Publications (2)

  • 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.

    PMID: 20943705DERIVED

  • 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.

    PMID: 19153091DERIVED

MeSH Terms

Conditions

Pregnancy, EctopicPre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesHypertension, Pregnancy-Induced

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Mervi Haapsamo, MD

    University Hospital of Oulu, Finland

    PRINCIPAL INVESTIGATOR

  • Juha Rasanen, MD

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

    STUDY DIRECTOR

  • Hannu Martikainen, MD

    University Hospital of Oulu, Finland

    STUDY DIRECTOR

  • Juha S Tapanainen, Prof

    University Hospital of Oulu, Finland

    STUDY DIRECTOR

  • Seppo Heinonen, Prof

    University Hospital of Kuopio, Finland

    STUDY DIRECTOR

  • Helena Tinkanen, MD

    Unversity Hospital of Tampere, Finland

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 21, 2008

First Posted

May 23, 2008

Study Start

March 1, 2001

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

May 23, 2008

Record last verified: 2001-03

Locations

FI(1)