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

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683202
• Other study ID #: 56/2001
• Status: Completed
• Phase: N/A
• First received: May 21, 2008
• Last updated: May 22, 2008
• Start date: March 2001
• Est. completion date: March 2006

Study information

• Verified date: March 2001
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• age < 40 years

• < 4 previous ovarian stimulations

Exclusion Criteria:

• allergy for acetylsalicylic acid

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Extrauterine Pregnancy
• Fetal Growth Retardation
• Intrauterine Fetal Growth Restriction
• Miscarriage Less Than 12 Gestational Weeks
• Preeclampsia
• Pregnancy
• Pregnancy, Ectopic

Intervention

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
• 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

Locations

Country	Name	City	State
Finland	University Hospital of Oulu, Department of Obstetrics and Gynecology	Oulu

Sponsors (4)

Lead Sponsor	Collaborator
University of Oulu	Bayer, Kuopio University Hospital, University of Tampere

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate		Five weeks after embryo transfer	No
Secondary	Uterine artery and spiral artery pulsatility index values		On the day of embryo transfer	No