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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Royan Institute
ClinicalTrials.gov Identifier:
NCT01633528
First received: May 14, 2012
Last updated: May 21, 2013
Last verified: March 2012
  Purpose

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.


Condition Intervention Phase
Infertility
Drug: Asprin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: To Evaluate the Effect of Low Dose Aspirin in Increasing the Chance of Pregnancy in Frozen Embryo Transfer Cycles

Resource links provided by NLM:


Further study details as provided by Royan Institute:

Primary Outcome Measures:
  • Pregnancy rate [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    evaluation the clinical pregnancy rate 6 weeks after emberyo transfering.


Secondary Outcome Measures:
  • Implantation rate [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Evaluation the implantation rate after emberyo transfer in women who use low dose of aspirin

  • Miscarriage rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Evaluation the miscariage rate after emberyo transfer in women who use asprin.


Enrollment: 60
Study Start Date: May 2012
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Exclusion Criteria:

  • The patients with history of recurrent abortion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01633528

Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Head of Royan institute
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
  More Information

Additional Information:
No publications provided

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01633528     History of Changes
Other Study ID Numbers: Royan-Emb-014
Study First Received: May 14, 2012
Last Updated: May 21, 2013
Health Authority: Iran: Ethics Committee
Iran: Ministry of Health

Keywords provided by Royan Institute:
low dose aspirin endometrial thickness pregnancy rate ICSI IVF embryo transfer

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 22, 2014