Effect of granulocyte colony-stimulating factor on fertility outcomes in infertile women with thin endometrium in frozen-thawed embryo transfer cycles.
this is a parallel, non-randomised, not blinded study that is designed for evaluation of granulocyte colony stimulating factor effect on the standard treatment of patients with thin endometrium in the frozen-thawed embryo transfer cycles. The endometrial thickness is measured by viginal sonography in the 13th day of frozen-thawed embryo transfer cycle. 40 patients with thin endometrium- which is less than 7mm- are taken part in the study. The patients are 20-40 years old and the patients who have uterine disorders, systemic diseases and sever endometriosis are excluded from the study. In the 13th day of treatment cycle, the factor is injected in to the uterus of 20 patients as a case group while the standard treatment is continued in the 20 other patients as a control group. After 2 days, the thickness of endometrium is measured again and if the thickness is at least 7mm, the patient will receive 100 milligram intramuscular progesteron for 3 days. Then embryo transfer is done. The primary outcome is the increase of endometrial thickness 2 days after factor ingestion. The second outcome is chemical pregnancy that is determined by serum B-hcg ,14 days after embryo transfer and clinical pregnancy that is determined by presence of gestational sac in vaginal sonography 28 days after embryo transfer.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108116420N8
Registration date:2013-12-21, 1392/09/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-12-21, 1392/09/30
Registrant information
Name
Maryam Eftekhar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35182470856
Email address
eftekhar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd reserch and clinical center for infertility
Expected recruitment start date
2013-09-25, 1392/07/03
Expected recruitment end date
2014-04-04, 1393/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of granulocyte colony-stimulating factor on fertility outcomes in infertile women with thin endometrium in frozen-thawed embryo transfer cycles.
Public title
Granulocyte colony stimulating factor administration in assisted reproductive programs.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all patients with thin endometrium in spite of receiving standard treatment in 12-13th day of frozen-thawed embryo transfer cycle. Exclusion criteria: all patient with history of hypersensitivity to G-CSF; endocrine or systemic diseases; endometriosis; repeated implantation failure; repeated abortion; patients with any cogenital uterine anomaly or aquired uterine diseases with or without operation; age below 20 years; age above 40 years.
Age
From 20 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not 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
Yazd reserch and clinical center for infertility
Street address
Bouali Ave, Safaeyeh
City
Yazd
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
216
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
endometrial thickness
Timepoint
13th and 17th day of menstural cycle
Method of measurement
vaginal sonography
Secondary outcomes
1
Description
chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
serum Bhcg
2
Description
clinical pregnancy
Timepoint
28 days after embryo transfer
Method of measurement
vaginal sonography
Intervention groups
1
Description
Intervention: 300 microgram granulocyte colony stimulating factor is injected into the uterus in the 13th day of menstural cycle.
Category
Treatment - Drugs
2
Description
Control: In the control group, no drug is injected into the uterus in the 13th day of menstural cycle.
Category
N/A
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 reaserch 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 reaserch 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 reaserch and clinical center for infertility
Full name of responsible person
Maryam Eftekhar
Position
assisted proffesor
Other areas of specialty/work
Street address
Bouali Avenue, Safayeh
City
yazd
Postal code
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
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
Maryam Eftekhar
Position
assisted professor
Other areas of specialty/work
Street address
Bouali Ave, Safaeyeh
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Full name of responsible person
Maryam Eftekhar
Position
assisted professor
Other areas of specialty/work
Street address
Bouali Ave, Safaeyeh
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)