This study tried to show how corticosteroid therapy improves the results of ICSI.
This semi clinical trial study) without control group (was included 248 infertile women were candidate to ICSI of Kosar infertility center in urmia university of medical sciences since 2011 to2013.Patiants were received Prednisolone that get started 20 mg/day from one day before embryo transfer to 7days then stopped. women were followed by pregnancy test (B-hCG), then in the 6 and 20 weeks by sonography. Incidence rate of Biochemical pregnancy, clinical pregnancy rate, incidence rate of abortion before appearance of fetal heart (6weeks), intra uterus pregnancy, incidence rate of abortion before 20weeks, Incidence rate of Ectopic pregnancy were compared between groups.
General information
Acronym
prednizolone and microinjection
IRCT registration information
IRCT registration number:IRCT2014111213421N2
Registration date:2015-01-10, 1393/10/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-01-10, 1393/10/20
Registrant information
Name
Fariba Nanbakhsh
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1346 7167
Email address
f.nanbakhsh@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Urmia University of Medical Sciences, Reproductive Health Reasearch Center
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2013-09-21, 1392/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Prednisolone on pregnancy outcomes among infertile patients undergoing Intra Cytoplasmic Sperm Injection (ICSI)
Public title
Prednisolone on pregnancy outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
i nclusion criteria: having infertility;FSH serum levels lower than 10 ,age of lower than 42 years
exclusion criteria: having asthma; systemic disorders; gastrointestinal disorders
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
248
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
Urmia University of Medical Sciences
Street address
Urmia, Urmia University of Medical Sciences
City
Urmia
Postal code
-
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
umsu.rec.1392.115
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97.9
ICD-10 code description
Female infertility, unspecified
Primary outcomes
1
Description
abortion
Timepoint
until 20 weeks
Method of measurement
observation
2
Description
intra uterus pregnancy
Timepoint
12,20 weeks
Method of measurement
sonography
3
Description
chemical pregnancy
Timepoint
6 weeks
Method of measurement
BHCG mesuring
Secondary outcomes
1
Description
none
Timepoint
none
Method of measurement
none
Intervention groups
1
Description
Control group: Patients who candidate for microinjection (ICSI), underwent for induction of ovulation, underwent by long protocol in the beginning of cycle. Determination of uterus depth was done for all patients. For all of patients were given 100 mg/12 hrs Doxycycline for 10 days and 1 mg daily Folic acid from the previous cycle, Contraceptive pills daily started on the second day of their menses and continued for 21 day. 50 line of insulin syringe Superfact (Buserelin) was injected sc. 6 days before menstruation. After end of 21 contraception pill consumption, on the second day of menstral cycle the injected dose of Superfact GnRH Antagonist (Buserelin) was reduced to half. First, we started gonadotropin (Gonal.F) S.C from second days, after 1 week , Gonal.F and menogone to given suitable follicles. Dose of gonadotropin was determined base on age, FSH level , amount of antral folicule and history of IVF. The size of the follicles and endometrial thickness was monitored by transvaginal sonography. Once at least 3 follicles reached the size of 18 mm, 10000 units hCG (FERRING-Germany) was injected to the patient. Ovum pick up was done 34 hours after the injection by transvaginal sonography under spinal or light general anesthesia were extracted. After 72 hours ,embryos were transferred in distance 1cm up to foundus of uterus. Same sequential media (GII series, VitrolifeTM ; Colorado, USA) was used for all embryo culturing. Embryo scoring was done according to zonal thickness, cytoplasm fragmentation, blastomeres number, and morphology. The clinician also made sure that the endometrium has three lines and its thickness is 8-10 mm. for luteal phase support 100 mg progesterone IM daily were given from ovum pick up day , detecting receiving positive β HCG results and detecting of fetal heart by sonography , respectively to 11 weeks of pregnancy.
Category
Treatment - Drugs
2
Description
Intervention Group also followed the same procedure as control groups and the same medications were used. In addition, 20 mg daily prednisolone was given to all Intervention Group, One day before the emberyo transfer, 20 mg daily prednisolone were used for one week. Prednisolone’s dose reduced to 10 mg daily for the second week and 5 mg daily in the last 2 days and then was stopped. One tablet Ranitidine also was used to prevent any possible stomach and intestinal discomfort in the morning.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Genecology Center
Full name of responsible person
Fariba Nanbakhsh
Street address
Urmia , Kashani Street , Motahari Hospital
City
Urmia
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
shamsimirigafarzadeh
Street address
Urmia , Djahad Avenue,PO BOX 1138, Urmia.Iran
City
Urmia
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Urmia University of Medical Sciences
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
Reproductive Health Research Center
Full name of responsible person
Fariba Nanbakhsh
Position
Membership of Research Council
Other areas of specialty/work
Street address
Urmia ,Kashani Street , Health Center No 6,Room NO 42
City
Urmia
Postal code
0443445138
Phone
+98 44 3344 5138
Fax
-
Email
-
Web page address
-
Person responsible for scientific inquiries
Contact
Name of organization / entity
Reproductive Health Research Center
Full name of responsible person
Fariba Nanbakhsh
Position
Assosiated of Genicology,Infertility
Other areas of specialty/work
Street address
Urmia,Kashani Street,Motahri Hospital
City
Urmia
Postal code
04433445138
Phone
+98 44 3344 5138
Fax
-
Email
f.nanbakhsh@umsu.ac.ir
Web page address
-
Person responsible for updating data
Contact
Name of organization / entity
Reproductive Health Research Center
Full name of responsible person
Sima Oshnouei
Position
Msc of Epidemiology
Other areas of specialty/work
Street address
Urmia, Kashani Street ,Reproductive Health Research Center, Room No 42
City
Urmia
Postal code
04433445138
Phone
+98 44 3344 5138
Fax
+98 44 3344 5138
Email
-
Web page address
-
Sharing plan
Deidentified Individual Participant Data Set (IPD)