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Clinical Trials/NCT01633528
NCT01633528
Completed
Phase 3

To Evaluate the Effect of Low Dose Aspirin in Increasing the Chance of Pregnancy in Frozen Embryo Transfer Cycles

Royan Institute1 site in 1 country60 target enrollmentMay 2012
ConditionsInfertility
InterventionsAsprinplacebo

Overview

Phase
Phase 3
Intervention
Asprin
Conditions
Infertility
Sponsor
Royan Institute
Enrollment
60
Locations
1
Primary Endpoint
Pregnancy rate
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

It has been reported that low-dose aspirin and Heparin would lead to an increased Pregnancy rate in patients undergoing IVF-ET. Low-dose aspirin may improve uterine and ovarian perfusion and that aspirin might enhance endometrial receptivity and ovarian responsiveness as well, which could result in better implantation and pregnancy rates after IVF or ICSI treatment. This study assesses potential effects of low-dose aspirin (100 mg daily) on pregnancy rate following frozen embryo transfer.

Detailed Description

In the present randomized double-blind prospective study, the patients will be randomly assigned to the study and control groups. With the onset of endometrial preparation and estrogen treatment, the study group will receive 100 mg of oral aspirin and the control group will be given placebo. When endometrial thickness will be found between 8-14 mm, therapy with progesterone (100 mg IM daily) will be started and embryo transfer will be performed 48 to 72 hours later. Doppler ultrasonography also is done to calculate Resistive Index (RI) and Pulsatility Index (PI), the day after progesterone administration. βHCG will be assessed 14 days after ET. If a pregnancy will be achieved, the patients in study and control groups will be instructed to continue the aspirin or placebo through 5 weeks and if the pregnancy test result will be negative, the treatment with aspirin or placebo will be stopped. The patients will be followed until 20 weeks of gestation and the results of treatment cycle will be compared in two groups.

Registry
clinicaltrials.gov
Start Date
May 2012
End Date
February 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with "long or antagonist" protocol
  • Women who did not achieve a pregnancy following a fresh embryo transfer or women whom their embryos had not been transferred due to OHSS
  • The women who had frozen embryos available for another transfer no contraindications for aspirin

Exclusion Criteria

  • The patients with history of recurrent abortion

Arms & Interventions

Asprin

With the onset of endometrial preparation and estrogen treatment, the study group will receive 100 mg of oral aspirin.

Intervention: Asprin

placebo

With the onset of endometrial preparation and estrogen treatment, the control group will receive placebo

Intervention: placebo

Outcomes

Primary Outcomes

Pregnancy rate

Time Frame: 6 weeks

evaluation the clinical pregnancy rate 6 weeks after emberyo transfering.

Secondary Outcomes

  • Implantation rate(8 weeks)
  • Miscarriage rate(12 weeks)

Study Sites (1)

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