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

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ClinicalTrials.gov Identifier: NCT01633528
Recruitment Status : Completed
First Posted : July 4, 2012
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Royan Institute

Tracking Information
First Submitted Date  ICMJE May 14, 2012
First Posted Date  ICMJE July 4, 2012
Last Update Posted Date January 18, 2017
Study Start Date  ICMJE May 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2012)
Pregnancy rate [ Time Frame: 6 weeks ]
evaluation the clinical pregnancy rate 6 weeks after emberyo transfering.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01633528 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2012)
  • Implantation rate [ Time Frame: 8 weeks ]
    Evaluation the implantation rate after emberyo transfer in women who use low dose of aspirin
  • Miscarriage rate [ Time Frame: 12 weeks ]
    Evaluation the miscariage rate after emberyo transfer in women who use asprin.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Low Dose Aspirin in Increasing the Chance of Pregnancy
Official Title  ICMJE To Evaluate the Effect of Low Dose Aspirin in Increasing the Chance of Pregnancy in Frozen Embryo Transfer Cycles
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Drug: Asprin
    100 mg
  • Drug: placebo
    100mg
Study Arms  ICMJE
  • Experimental: Asprin
    With the onset of endometrial preparation and estrogen treatment, the study group will receive 100 mg of oral aspirin.
    Intervention: Drug: Asprin
  • Placebo Comparator: placebo
    With the onset of endometrial preparation and estrogen treatment, the control group will receive placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 1, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01633528
Other Study ID Numbers  ICMJE Royan-Emb-014
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Royan Institute
Study Sponsor  ICMJE Royan Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Royan Institute
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP