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

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

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Drug: Asprin; Drug: placebo

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Royan Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Asprin; With the onset of endometrial preparation and estrogen treatment, the study group will receive 100 mg of oral aspirin.	Drug: Asprin; 100 mg
Placebo Comparator: placebo; With the onset of endometrial preparation and estrogen treatment, the control group will receive placebo	Drug: placebo; 100mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy rate	evaluation the clinical pregnancy rate 6 weeks after emberyo transfering.	6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Royan Institute
• Investigators: Study Director: Tahereh Madani, MD, Endocrinology and Female Infertility Department; Principal Investigator: Firoozeh Ahmadi, MD, Reproductive Imaging Department; Principal Investigator: Poopak Eftekhary, PhD, Embryology Department

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: May 14, 2012
• First Submitted That Met QC Criteria: July 1, 2012
• First Posted (Estimate): July 4, 2012

Study Record Updates

• Last Update Posted (Estimate): January 18, 2017
• Last Update Submitted That Met QC Criteria: January 15, 2017
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: low dose aspirin endometrial thickness pregnancy rate ICSI IVF embryo transfer
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: Royan-Emb-014