This prospective controlled trial was designed to determine whether an additional GnRH agonist administered at the time of implantation for luteal phase support in FET cycles improves the pregnancy outcome in frozen-thawed embryo transfer cycles (FET) cycles. Inclision criteria was:frozen-thawed embryo transfer cycles;age 17 to 42 years.Exclusion criteria:history of endocrine or systemic diseases; endometriosis; cogenital uterine anomaly or aquired uterine diseases with or without operation; age below 17 years or above 42 years. In 200 FET cycles,Patients were administered estradiol valerate 6 milligrams daily and ASA 80 mg from day 2 of the cycle.vaginal sonography eas done on day ; since the endometrial thickness reached 8 mm,daily vaginal progesterone suppositories(total dose 800 mg daily) was administered . Randomization was done on the day of embryo transfer by a computer-generated table.Blindness was done for researchers.Patients were divided to group 1(n=100) to whom a single dose of GnRH agonist( 0.1 mg triptorelin) was administered three days after transfer and group 2 (n=100) ,who did not receive agonist.Both groups received daily vaginal progesterone suppositories(800 mg daily) plus estradiol valerate( 6 mg dai-ly).primary outcome measure was clinical pregnancy rate.secondary outcome measures were implantation rate,chemical ,ongoing pregnancy rate and abortion rate ..
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015031021420N1
Registration date:2015-04-12, 1394/01/23
Registration timing:retrospective
Last update:
Update count:1
Registration date
2015-04-12, 1394/01/23
Registrant information
Name
Maryam Farid Mojtahedi
Name of organization / entity
Arash women hospital,clinic for infertility,Tehran university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 8755
Email address
m_fmojtahedi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Yazd University of Medical Sciences
Expected recruitment start date
2014-01-21, 1392/11/01
Expected recruitment end date
2015-01-21, 1393/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of single dose of GnRH-agonist on pregnancy outcome in frozen-thawed embryo transfer cycles
Public title
GnRH agonist administration in assisted reproductive program
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients in frozen-thawed embryo transfer cycle who have freezed embryo due to previous OHSS or supernumerary freezed embryos; age of 17 to 40years. Exclusion criteria: oocyte recipients;history of endocrine or systemic diseases; endometriosis; cogenital uterine anomaly or aquired uterine diseases with or without operation; age below 17 years or above 40 years.
Age
From 17 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A computer-generated randomization table was created for
the study population .Allocation concealment was ensured by the use of sealed envelopes on the day of embryo transfer
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical commitee of Shahid Sadoughi University of Medical Sciences
Street address
Bouali Ave, Safaeyeh
City
yazd
Postal code
8916877391
Approval date
2014-06-22, 1393/04/01
Ethics committee reference number
314
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
clinical pregnancy
Timepoint
28 days after transfer
Method of measurement
vaginal sonography
Secondary outcomes
1
Description
chemical pregnancy
Timepoint
14 days after transfer
Method of measurement
BHCG test
Intervention groups
1
Description
intervention group:a single dose of GnRH agonist( 0.1 mg triptorelin) was administered three days after transfer
Category
Treatment - Drugs
2
Description
Control group do not receive triptoreline0.1mg.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd reserch and clinical center for infertility
Full name of responsible person
abbas aflatoonian
Street address
Bouali Avenue, Safayeh
City
yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd Research and Clinical center for infertility
Full name of responsible person
Alimohammad Abdoli
Street address
Bouali Avenue, Safayeh
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd Research and Clinical center for infertility
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 Reserch and Clinical center for infertility
Full name of responsible person
Dr.Robab Davar
Position
Associate professor
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
r_davar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd Reaserch and Clinical Center for infertility
Full name of responsible person
Dr. Maryam faridMojtahedi
Position
Fellowship of infertility
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
m_fmojtahedi@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Reaserch and Clinical Center for infertility
Full name of responsible person
Dr.Robab Davar
Position
Assoiate Professor
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
Email
r_davar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)