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OpenTrials
Completed

NCT Number: NCT01633528

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Royan Institute

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

asprin

Drug

100 mg

Placebo

Drug

100mg

Primary outcomes

  1. Pregnancy rate

    Time frame: 6 weeks

    evaluation the clinical pregnancy rate 6 weeks after emberyo transfering.

Secondary outcomes

  1. Implantation rate

    Time frame: 8 weeks

    Evaluation the implantation rate after emberyo transfer in women who use low dose of aspirin

  2. Miscarriage rate

    Time frame: 12 weeks

    Evaluation the miscariage rate after emberyo transfer in women who use asprin.

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2015
First posted
Jul 4, 2012
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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