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

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ClinicalTrials.gov Identifier: NCT00683202
Recruitment Status : Completed
First Posted : May 23, 2008
Last Update Posted : May 23, 2008
Sponsor:
Collaborators:
Bayer
Kuopio University Hospital
University of Tampere
Information provided by:
University of Oulu

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.

Condition or disease Intervention/treatment Phase
Pregnancy Miscarriage Less Than 12 Gestational Weeks Extrauterine Pregnancy Preeclampsia Intrauterine Fetal Growth Restriction Drug: Acetylsalicylic acid Drug: Placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
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 Start Date : March 2001
Actual Primary Completion Date : March 2006
Actual Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Active Comparator: 1
Acetylsalicylic acid 100 mg daily perorally
Drug: 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
Other Name: Low-dose aspirin

Placebo Comparator: 2
Placebo daily perorally
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




Primary Outcome Measures :
  1. Pregnancy rate [ Time Frame: Five weeks after embryo transfer ]

Secondary Outcome Measures :
  1. Uterine artery and spiral artery pulsatility index values [ Time Frame: On the day of embryo transfer ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age < 40 years
  • < 4 previous ovarian stimulations

Exclusion Criteria:

  • allergy for acetylsalicylic acid

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00683202


Locations
Finland
University Hospital of Oulu, Department of Obstetrics and Gynecology
Oulu, Finland, 90220
Sponsors and Collaborators
University of Oulu
Bayer
Kuopio University Hospital
University of Tampere
Investigators
Principal Investigator: Mervi Haapsamo, MD University Hospital of Oulu, Finland
Study Director: 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mervi Haapsamo/MD, University Hospital of Oulu
ClinicalTrials.gov Identifier: NCT00683202     History of Changes
Other Study ID Numbers: 56/2001
First Posted: May 23, 2008    Key Record Dates
Last Update Posted: May 23, 2008
Last Verified: March 2001

Keywords provided by University of Oulu:
Assisted reproduction
Ovarian response
Uteroplacental hemodynamics
Doppler ultrasonography
Implantation rate
Pregnancy rate
Live birth rate

Additional relevant MeSH terms:
Pre-Eclampsia
Abortion, Spontaneous
Fetal Growth Retardation
Pregnancy, Ectopic
Hypertension, Pregnancy-Induced
Pregnancy Complications
Fetal Diseases
Growth Disorders
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics