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

Primary Purpose

Infertility

Status

Completed

Phase

Phase 3

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Asprin

placebo

About this trial

This is an interventional treatment trial for Infertility focused on measuring low dose aspirin endometrial thickness pregnancy rate ICSI IVF embryo transfer

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Royan Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Asprin

placebo

Arm Description

With the onset of endometrial preparation and estrogen treatment, the study group will receive 100 mg of oral aspirin.

With the onset of endometrial preparation and estrogen treatment, the control group will receive placebo

Outcomes

Primary Outcome Measures

Pregnancy rate

evaluation the clinical pregnancy rate 6 weeks after emberyo transfering.

Secondary Outcome Measures

Implantation rate

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

Miscarriage rate

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

Full Information

NCT ID

NCT01633528

First Posted

May 14, 2012

Last Updated

January 15, 2017

Sponsor

Royan Institute

1. Study Identification

Unique Protocol Identification Number

NCT01633528

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

May 2012 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Royan Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility

Keywords

low dose aspirin endometrial thickness pregnancy rate ICSI IVF embryo transfer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Asprin

Arm Type

Experimental

Arm Description

With the onset of endometrial preparation and estrogen treatment, the study group will receive 100 mg of oral aspirin.

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

With the onset of endometrial preparation and estrogen treatment, the control group will receive placebo

Intervention Type

Drug

Intervention Name(s)

Asprin

Intervention Description

100 mg

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

100mg

Primary Outcome Measure Information:

Title

Pregnancy rate

Description

evaluation the clinical pregnancy rate 6 weeks after emberyo transfering.

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Implantation rate

Description

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

Time Frame

8 weeks

Title

Miscarriage rate

Description

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

Time Frame

12 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility 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 no contraindications for aspirin Exclusion Criteria: The patients with history of recurrent abortion

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hamid Gourabi, PhD

Organizational Affiliation

Head of Royan institute

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Tahereh Madani, MD

Organizational Affiliation

Endocrinology and Female Infertility Department

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Firoozeh Ahmadi, MD

Organizational Affiliation

Reproductive Imaging Department

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Poopak Eftekhary, PhD

Organizational Affiliation

Embryology Department

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royan Institute

City

Tehran

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Links:

URL

http://Royaninstitute.org

Description

Related Info

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

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