In IVF cycle make an effort to improving the outcome and minimize cost and decrease the risk of OHSS. The study is designed as prospective randomized clinical trial.110 patients who are candidates for IVF in Yazd research and clinical center for infertility is evaluated from March 2011 to March 2012. Inclusion criteria: regular menstrual cycle, age between 20 to 38 years old. Exclusion criteria: endometriosis, azoospermia. On day 2 of the menstrual cycle, all patients receive daily injection of gonadotropin .Randomly, in 55 patients as interventional group, when at least 6 follicles of more than 12 mm are present on ultrasound, gonadotropin is substituted by 200 IU hCG/day .In control group (55 patients) gonadotropin is continued. In both groups when two co dominant follicles reach 13-14 mm administration of the GnRH antagonist cetrorelix is started at a daily dose of 0.25mg sc and extended until the day of final follicle maturation (defined by ultrasound detection of more than 2 follicles which more than 18mm in size).Subsequently 10000 IU hCG is injected IM to accommodate oocyte retrieval within 36 hours. Embryo transfer is performed on day 3 after oocyte retrieval. Clinical pregnancy, number of oocyte‚ duration of stimulation and total dose of gonadotropin compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108044339N7
Registration date:2011-09-26, 1390/07/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-09-26, 1390/07/04
Registrant information
Name
Elham Rahmani
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77125265914
Email address
rahmani@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd research and clinical center for infertility
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Low – dose human chorionic gonadotropin in the late follicular phase in GnRH – antagonist protocol in infertile women
Public title
human chorionic gonadotropin GnRH – antagonist in IVF
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: regular menstrual cycle; age between 20 to 38 years old,FSH less than 12,esteradiol less than 60 pg/ml.
Exclusion criteria: endometriosis; azoospermia,polycystic ovary,hystory of poor ovarian response.
Age
From 20 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
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
Yazd research and clinical center for infertility
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Postal code
8916877391
Approval date
2011-08-08, 1390/05/17
Ethics committee reference number
1478
Health conditions studied
1
Description of health condition studied
female infertility
ICD-10 code
N97
ICD-10 code description
female infertility
Primary outcomes
1
Description
the number of oocyte retrival
Timepoint
the day of puncture
Method of measurement
counting by microscope
Secondary outcomes
1
Description
chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
serum BHCG
Intervention groups
1
Description
In interventional group, 55 patients on day 2 of the menstrual cycle receive daily injection of gonadotropin and when at least 6 follicles with 12 mm in size, are present on ultrasound, gonadotropin is substituted by 200 IU hCG/day. When two dominant follicles reach 13-14 mm, administration of the GnRH antagonist cetrorelix is started at a daily dose of 0.25mg subcutaneous and extended until the day of final follicle maturation (defined by ultrasound detection of more than 2 follicles with more than 18mm).subsequently 10000 IU HCG is injected IM to accommodate oocyte retrieval within 36 hours. Embryo transfer is performed on day 3 after oocyte retrieval.
Category
Treatment - Drugs
2
Description
In control group, 55 patients on day 2 of the menstrual cycle, receive daily injection of gonadotropin and When two dominant follicles reach 13-14 mm administration of the GnRH antagonist cetrorelix is started at a daily dose of 0.25mg subcutaneous and extended until the day of final follicle maturation (defined by ultrasound detection of more than 2 follicles which more than 18mm).Subsequently 10000 IU hCG is injected IM to accommodate oocyte retrieval within 36 hours. Embryo transfer is performed on day 3 after oocyte retrieval.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd research and clinical center for infertility
Full name of responsible person
Di Razieh Dehghani Firoozabadi
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Dr Razieh Dehghani Firoozabadi
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
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 research and clinical center for infertility
Full name of responsible person
Dr Mozhgan Rahsepar
Position
Obestetrics and Gynecologist,Student of fellowship
Other areas of specialty/work
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
drrahsepar@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Dr Razieh Dehghani Firoozabadi
Position
Obestetrics and Gynecologist, fellowship of infertility
Other areas of specialty/work
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
dr_firouzabadi@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)