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CompletedNCT00683202Updated May 23, 2008

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

An interventional study of Acetylsalicylic acid and Placebo in Pregnancy, Miscarriage Less Than 12 Gestational Weeks and Extrauterine Pregnancy, sponsored by University of Oulu. Completed at 1 site in Finland. Open to female participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2008-05-23.

Sponsored by University of Oulu · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
374
Allocation
Randomized
Ages
18 Years to 39 Years
Sex
Female
01

Study 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.

Read the 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.

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Conditions studied

  • 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
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In context

Pre-Eclampsia

882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.

This study's enrollment of 374 is above the median of 110 across 468 interventional studies indexed under Pre-Eclampsia.

Browse Pre-Eclampsia studies →

Lead sponsor

University of Oulu is the lead sponsor of 138 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • allergy for acetylsalicylic acid
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
374 participants (actual)

Study arms

  • Active comparator
    1

    Acetylsalicylic acid 100 mg daily perorally

    Drug: Acetylsalicylic acid

  • Placebo comparator
    2

    Placebo daily perorally

    Drug: Placebo

Interventions

  • DrugAcetylsalicylic 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

    Also known as: Low-dose aspirin

  • DrugPlacebo

    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

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What researchers measure

Primary outcomes

  1. Pregnancy rate

    Time frame: Five weeks after embryo transfer

Secondary outcomes

  1. Uterine artery and spiral artery pulsatility index values

    Time frame: On the day of embryo transfer

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Study locations

1 site
  • University Hospital of Oulu, Department of Obstetrics and Gynecology
    Oulu, 90220, Finland
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References and documents

Publications

  • 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. PubMed 20943705 ↗
  • 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. PubMed 19153091 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00683202
Lead sponsor
University of Oulu
Collaborators
Bayer, Kuopio University Hospital, Tampere University
First posted
May 23, 2008
Start date
Mar 2001
Primary completion
Mar 2006
Completion
Mar 2006
Last update
May 23, 2008

Study contacts

Mervi Haapsamo, MD
principal investigator · University Hospital of Oulu, Finland
Juha Rasanen, MD
study director · University Hospital of Oulu, Finland and Oregon Health Sciences University, Oregon USA
Hannu Martikainen, MD
study director · University Hospital of Oulu, Finland
Juha S Tapanainen, Prof
study director · University Hospital of Oulu, Finland
Seppo Heinonen, Prof
study director · University Hospital of Kuopio, Finland
Helena Tinkanen, MD
study director · Unversity Hospital of Tampere, Finland

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2001. You cannot join it, but the record below documents what was studied.

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