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.
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. Vaginal sonography will be done 2 weeks after the positive result of pregnancy for observation of gestational sac.
At first, the study will be performed on 60 patients (30 in each group) as a pilot study. Then the sample size will be calculated by the results.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205131141N12
Registration date:2012-07-13, 1391/04/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-13, 1391/04/23
Registrant information
Name
Kiandokht Kiani
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2230 7960
Email address
kiandokht.kiani@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Royan Institute
Expected recruitment start date
2012-05-01, 1391/02/12
Expected recruitment end date
2015-02-07, 1393/11/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To evaluate the effect of low dose Aspirin in increasing the chance of pregnancy in frozen embryo transfer cycles
Public title
The effect of low dose Aspirin in increasing the chance of pregnancy
Purpose
Treatment
Inclusion/Exclusion 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, contraindications for aspirin.
Age
From 18 years old to 40 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
The patients will be followed until 20 weeks of gestation and the results of treatment cycle will be compared in two groups. Data analysis will be performed by means of SPSS software program.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Royan Institute
Street address
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way
City
Tehran
Postal code
16635148
Approval date
2011-02-15, 1389/11/26
Ethics committee reference number
1065/ 89/ EC
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
4-6 weeks after embryo transfer
Method of measurement
Ultrasound visualization of a gestational sac
Secondary outcomes
1
Description
Implantation rate
Timepoint
4-6 weeks after embryo transfer
Method of measurement
Number of sacs by Sonography
2
Description
Early abortion
Timepoint
Week 12
Method of measurement
Sonography
3
Description
Biochemical pregnancy
Timepoint
2 weeks after embryo transfer
Method of measurement
BhCG test
4
Description
Endometrial thickness
Timepoint
Third day & Embryo transfer day
Method of measurement
Sonography
5
Description
Late abortion
Timepoint
Week 20
Method of measurement
Sonography
Intervention groups
1
Description
With the onset of endometrial preparation and estrogen treatment, the study group will receive 100 mg of oral aspirin.
Category
Treatment - Drugs
2
Description
With the onset of endometrial preparation and estrogen treatment, the control group will receive placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Royan Institute
Full name of responsible person
Dr.Tahereh Madani
Street address
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Royan Institute
Full name of responsible person
Dr. Ahmad Vosugh
Street address
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Royan Institute
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Roan Institute
Full name of responsible person
Dr.Tahereh Madani
Position
gynecologist
Other areas of specialty/work
Street address
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way
City
Tehran
Postal code
Iran
Phone
+98 21 2235 2008
Fax
+98 21 2230 6481
Email
tmadani@royaninstitute.org
Web page address
www.royaninstitute.org
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Dr Tahereh Madani
Position
Gynecologist
Other areas of specialty/work
Street address
Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way
City
Tehran
Postal code
1663
Phone
+98 21 2235 2000
Fax
+98 21 2230 6481
Email
tmadani@royaninstitute.org5148
Web page address
www.royaninstitute.org
Person responsible for updating data
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Dr.Tahereh Madani
Position
Gynecologist
Other areas of specialty/work
Street address
Address: Royan Institute, Number 12, East Hafez Avenue, Bani Hashem Street, Resalat high way, Tehran, Iran
City
Tehran
Postal code
16635148
Phone
+98 21 2235 2000
Fax
+98 21 2230 6481
Email
tmadani@royaninstitute.org
Web page address
www.royaninstitute.org
Sharing plan
Deidentified Individual Participant Data Set (IPD)