Effect of sildenafil citrate on endometrial preparation and on the outcome of the frozen-thawed embryo transfer cycles in infertile women: a clinical trial
Purpose: The aim of this study is to estimate the effect of sildenafil on endometrial thickness, endometrial pattern, and investigate estrogen level on the day of progesterone administration, the implantation rate and chemical pregnancy rate in frozen embryo transfer cycles .
Methods: 80 women younger than 40 years who had high quality frozen embryos with history of poor endometrial response were included in the study and based on random allocation are divided in two groups. For group I (n=40) start 2mg estradiol valerat (tablet) from first to 4th day of the menstrual cycle, and continue by 4mg from 5th to 8th day, and 6mg from 9th to 20th day of the menstrual cycle.
In the second group (n=40) in addition to the above treatment protocol, from first day of cycle until the day of starting progesterone will be given 50mg sildenafil citrate tablets daily and it was discontinued from 48 to 72 hr prior to the embryo transfer.
In 13th day of the menstrual cycle endometrial thickness measured with transvaginal ultrasonography (arranged in a series every other day). Evaluations were performed by a single investigato. If the endometrial thickness is more than 8mm, 100 mg progesterone injected intramuscular and blood estrogen, progesterone level are measured then after three days embryo was transferred.
Outcomes: Estradiol valerat and progesterone continued until two weeks after embryo transferred, then BHCG tested. If BHCG is positive, estradiol valerat and progesterone continues until 11 weeks of pregnancy . Then four weeks after the embryo transfer, the number of gestational sac are determined by vaginal ultrasound.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201210232575N3
Registration date:2012-12-24, 1391/10/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-12-24, 1391/10/04
Registrant information
Name
Razieh ِDehghani Firouzabadi
Name of organization / entity
Yazd Research and Clinilcal Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 7085
Email address
dr_firouzabadi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Shahid Sadoughi University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2009-03-20, 1387/12/30
Expected recruitment end date
2011-03-20, 1389/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of sildenafil citrate on endometrial preparation and on the outcome of the frozen-thawed embryo transfer cycles in infertile women: a clinical trial
Public title
Effect of sildenafil citrate on endometrial preparation and on the outcome of the frozen-thawed embryo transfer cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All infertile women have high quality frozen embryos.
Exclusion criteria:
1. Age> 40
2. History of endocrine disease such as: diabetes; Hyperthyroidism and Hyperprolactinemia
3. History of hysteroscopic surgery due to intrauterine adhesions
4. History of cardiovascular, renal or liver disease
5. Hypotension( blood pressure<90/50)
6. History of stroke or myocardial infarction
7. Poor quality embryos
8. Alcohol or Substance abuse
Age
From 15 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research and Clinical Center for Infertility, Yazd Shahid Sadoughi University of Medical Sciences
Street address
Bouali Ave., Safaeih, Research and Clinical Center for Infertility, Yazd, Iran.
City
Yazd
Postal code
8916877391
Approval date
2011-03-10, 1389/12/19
Ethics committee reference number
3428
2
Ethics committee
Name of ethics committee
ٍEthics Committee of Research and Clinical Center for Infertility, Yazd Shahid Sadoughi University o
Street address
Bouali Ave., Safaeih, Research and Clinical Center for Infertility, Yazd, Iran.
City
Yazd
Postal code
8916877391
Approval date
2011-05-22, 1390/03/01
Ethics committee reference number
647
Health conditions studied
1
Description of health condition studied
Female Infertility
ICD-10 code
N98.3
ICD-10 code description
Complications of attempted introduction of embryo in embryo transfer
Primary outcomes
1
Description
Endometrial thickness
Timepoint
ٌWithin a day from 13th day of the menstrual cycle
Method of measurement
Vaginal sonoghraphy
2
Description
Chemical pregnancy
Timepoint
Two weeks after embryo transfer
Method of measurement
BHCG test
Secondary outcomes
1
Description
Duration of infertility
Timepoint
Before intervention
Method of measurement
Patient's medical record
2
Description
Implantation rate
Timepoint
Four weeks after the embryo transfer
Method of measurement
Number of gestational sac are determined by vaginal ultrasound
3
Description
FSH, LH, FSH/LH level
Timepoint
ratio in progesterone day administration
Method of measurement
Blood sample
Intervention groups
1
Description
For group I start 2mg estradiol valerat (tablet) from first to 4th day of the menstrual cycle, and continue by 4mg from 5th to 8th day, and 6mg from 9th to 20th day of the menstrual cycle. In 13th day of the menstrual cycle endometrial thickness estimated with transvaginal ultrasonography (arranged in a series every other day), evaluations were performed by a single investigator, if the endometrial thickness is more than 8mm, 100 mg progesterone injected intramuscular and after three days embryo was transferred. Estradiol valerat and progesterone continued until two weeks after embryo transferred, then BHCG tested. If BHCG is positive, estradiol valerat and progesterone continues until 11 weeks of pregnancy . Then four weeks after the embryo transfer, the number of gestational sac are determined by vaginal ultrasound.
Category
Treatment - Drugs
2
Description
In the group II in addition to the above treatment protocol, from first day of cycle until the day of starting progesterone will be given 50mg sildenafil citrate tablets daily and it was discontinued between 48-72 hours previous of the embryo transfer. In 13th day of the menstrual cycle endometrial thickness estimated with transvaginal ultrasonography (arranged in a series every other day), evaluations were performed by a single investigator, if the endometrial thickness is more than 8mm, 100 mg progesterone injected intramuscular and after three days embryo was transferred. Estradiol valerat and progesterone continued until two weeks after embryo transferred, then BHCG tested. If BHCG is positive, estradiol valerat and progesterone continues until 11 weeks of pregnancy . Then four weeks after the embryo transfer, the number of gestational sac are determined by vaginal ultrasound.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Research and Clinical Center for Infertility
Full name of responsible person
Dr. Razeih Dehghani Firouzabadi
Street address
Research and Clinical Center for Infertility, Bouali Ave., Safaeih, Yazd, Iran.
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd Shahid Sadoughi University of Medical Sciences and Health Services, Vice Chancellor for resear
Full name of responsible person
Dr. ّFatemeh Ezaddini
Street address
Bahonar SQ., Vice Chancellor for Research Office, Yazd Shahid Sadoughi University of Medical Sciences and Health Services,Yazd, Iran.
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Shahid Sadoughi University of Medical Sciences and Health Services, Vice Chancellor for resear
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
Yazd Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Razieh Dehghani Firouzabadi
Position
Gynecologist
Other areas of specialty/work
Street address
Yazd Research and Clinical Center for Infertility, Bouali Ave., Safaeih, Yazd, Iran.
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
dr_firouzabai@ssu.ac.ir; pkhani55@gmail.com
Web page address
www.yazd-rsi.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Razieh Dehghani Firouzabadi
Position
Gynecologist
Other areas of specialty/work
Street address
Yazd Research and Clinical Center for Infertility, Bouali Ave., Safaeih, Yazd, Iran.
City
Yazd
Postal code
8916877391
Phone
+98 35 1825 7085
Fax
+98 35 1824 7087
Email
dr_firouzabai@ssu.ac.ir, pkhani55@gmail.com
Web page address
www.yazd-rsi.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Razieh Dehghani Firouzabadi
Position
Gynecologist
Other areas of specialty/work
Street address
Yazd Research and Clinical Center for Infertility, Bouali Ave., Safaeih, Yazd, Iran.
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7985
Fax
+98 82 47078
Email
dr_firouzabai@ssu.ac.ir, pkhani55@gmail.com
Web page address
www.yazd-rsi.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)