NCT01633528

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

January 18, 2017

Status Verified

March 1, 2012

Enrollment Period

4 months

First QC Date

May 14, 2012

Last Update Submit

January 15, 2017

Conditions

Keywords

low dose aspirin endometrial thickness pregnancy rate ICSI IVF embryo transfer

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    evaluation the clinical pregnancy rate 6 weeks after emberyo transfering.

    6 weeks

Secondary Outcomes (2)

  • Implantation rate

    8 weeks

  • Miscarriage rate

    12 weeks

Study Arms (2)

Asprin

EXPERIMENTAL

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

Drug: Asprin

placebo

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

AsprinDRUG

100 mg

Asprin

100mg

placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • The patients with history of recurrent abortion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royan Institute

Tehran, Iran

Location

Related Links

MeSH Terms

Conditions

Infertility

Interventions

acetylsalicylic acid lysinate

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Hamid Gourabi, PhD

    Head of Royan institute

    STUDY CHAIR
  • Tahereh Madani, MD

    Endocrinology and Female Infertility Department

    STUDY DIRECTOR
  • Firoozeh Ahmadi, MD

    Reproductive Imaging Department

    PRINCIPAL INVESTIGATOR
  • Poopak Eftekhary, PhD

    Embryology Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2012

First Posted

July 4, 2012

Study Start

May 1, 2012

Primary Completion

September 1, 2012

Study Completion

February 1, 2015

Last Updated

January 18, 2017

Record last verified: 2012-03

Locations