The Effect of Low Dose Aspirin in Increasing the Chance of Pregnancy

Phase 3

Completed

• Conditions: Infertility
• Interventions: Drug: Asprin; Drug: placebo

• Registration Number: NCT01633528
• Lead Sponsor: Royan Institute

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.

Study Timeline

• Status Verified: 2012-03
• Study Start: 2012-05
• Study First Submitted: 2012-05-14
• Study First Submitted QC: 2012-07-01
• Study First Posted: 2012-07-04
• Primary Completion: 2012-09
• Study Completion: 2015-02
• Last Update Submitted: 2017-01-15
• Last Update Posted: 2017-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Asprin	Asprin	With the onset of endometrial preparation and estrogen treatment, the study group will receive 100 mg of oral aspirin.
placebo	placebo	With the onset of endometrial preparation and estrogen treatment, the control group will receive placebo

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	6 weeks	evaluation the clinical pregnancy rate 6 weeks after emberyo transfering.

Secondary Outcome Measures

Name	Time	Method
Implantation rate	8 weeks	Evaluation the implantation rate after emberyo transfer in women who use low dose of aspirin
Miscarriage rate	12 weeks	Evaluation the miscariage rate after emberyo transfer in women who use asprin.

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of