Clinical trial NCT00683202: Low-Dose Aspirin in in Vitro Fertilization (IVF) and Intracytoplasmic Sperm Injection (ICSI) Treatments
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: Bayer
name: Kuopio University Hospital
name: Tampere University
First posted: 2008-05-23
Enrollment: 374
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* allergy for acetylsalicylic acid

Primary outcomes:
measure: Pregnancy rate
timeFrame: Five weeks after embryo transfer
Secondary outcomes:
measure: Uterine artery and spiral artery pulsatility index values
timeFrame: On the day of embryo transfer
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: University Hospital of Oulu, Department of Obstetrics and Gynecology
Study officials:
affiliation: University Hospital of Oulu, Finland
name: Mervi Haapsamo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital of Oulu, Finland and Oregon Health Sciences University, Oregon USA
name: Juha Rasanen, MD
role: STUDY_DIRECTOR
affiliation: University Hospital of Oulu, Finland
name: Hannu Martikainen, MD
role: STUDY_DIRECTOR
affiliation: University Hospital of Oulu, Finland
name: Juha S Tapanainen, Prof
role: STUDY_DIRECTOR
affiliation: University Hospital of Kuopio, Finland
name: Seppo Heinonen, Prof
role: STUDY_DIRECTOR
affiliation: Unversity Hospital of Tampere, Finland
name: Helena Tinkanen, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.