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Completed

NCT Number: NCT00683202

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

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.

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Key information

Conditions

Pregnancy Extrauterine Pregnancy Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Intrauterine Fetal Growth Restriction Miscarriage Less Than 12 Gestational Weeks Pre-Eclampsia Preeclampsia Pregnancy Complications Pregnancy, Ectopic Urogenital Diseases

Age range

18 year–39 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Oulu, Department of Obstetrics and Gynecology

Oulu, 90220, Finland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age < 40 years
  • < 4 previous ovarian stimulations

Exclusion criteria

  • allergy for acetylsalicylic acid

Treatment and study plan

acetylsalicylic acid

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

Other names: Low-dose aspirin

Placebo

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

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

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Collaborators

  • Bayer
  • Kuopio University Hospital
  • Tampere University

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
May 23, 2008
Registry last updated
May 23, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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