In this Randomized clinical trial, 300 normo-responders undergoing IVF were randomly divided to GnRh agonist (n=150) and GnRh antagonist (n=150) groups.
In the agonist group on cycle day 21, Busereline acetate was started as 0.5 mg daily (S.C.) injection until menstruation had begun. At day 3 of next menstrual cycle, the dose of Busereline was diminished to 0.2 mg and rFSH was started and the dose was adjusted on the basis of follicle graph using Gonal-F and HMG.
In the antagonist group rFSH treatment was begun on day 3 of menstrual cycle and the dose was adjusted on the basis of follicle graph using Gonal-F and HMG When there was one follicle 14mm in diameter antagonist (Cetrotide), 0.25 mg S.C. daily dose was administrated until the day of HCG administration.
In both groups when at least 2 follicles 18-20 mm in diameter were seen, rFSH and HCG (10000 IU, IM) was injected.
The main outcome measurements were chemical, clinical and ongoing pregnancy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902283950N1
Registration date:2011-06-19, 1390/03/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-19, 1390/03/29
Registrant information
Name
Mina Jafarabadei
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1616
Email address
jafarabadi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2008-01-01, 1386/10/11
Expected recruitment end date
2010-01-01, 1388/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Gonadotropin-releasing hormone antagonist vs agonist in Iranian normo-responders undergoing in vitro fertilisation: A Randomized Clinical Trial
Public title
Gonadotropin-releasing hormone antagonist vs agonist in Iranian normo-responders undergoing in vitro fertilisation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age <38 years; normal basal serum FSH; 20 ≤ BMI <30 kg/m2; regular menstrual cycle. Exclusion criteria: Polycystic ovary syndrome; severe endometriosis; history of poor response in previous treatment cycles; history of repeated IVF failure more than 3 cycles failed.
Age
From 18 years old to 38 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Vali- e-Asr Reproductive Health Research Center
Street address
Reproductive Health Research center, Emam Hospital, Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2007-12-09, 1386/09/18
Ethics committee reference number
م/ا/0071
Health conditions studied
1
Description of health condition studied
response to controlled ovarian stimulation
ICD-10 code
Z31.2
ICD-10 code description
In vitro fertilization
Primary outcomes
1
Description
pregnancy
Timepoint
after one cycle of controlled ovarian stimulation
Method of measurement
chemical, clinical and ongoing pregnancy
Secondary outcomes
1
Description
number of retrieved oocytes
Timepoint
after one cycle of controlled ovarian stimulation
Method of measurement
counting by light microscope
Intervention groups
1
Description
In the agonist group on cycle day 21, Busereline acetate was started as 0.5 mg daily (S.C.) injection until menstruation had begun. At day 3 of next menstrual cycle, the dose of Busereline was diminished to 0.2 mg and rFSH was started and the dose was adjusted on the basis of follicle graph using Gonal-F and HMG. When at least 2 follicles 18-20 mm in diameter were seen, rFSH and HCG (10000 IU, IM) was injected.
Category
Treatment - Drugs
2
Description
In the antagonist group rFSH treatment was begun on day 3 of menstrual cycle and the dose was adjusted on the basis of follicle graph using Gonal-F and HMG When there was one follicle 14mm in diameter antagonist (Cetrotide), 0.25 mg S.C. daily dose was administrated until the day of HCG administration. When at least 2 follicles 18-20 mm in diameter were seen, HCG (10000 IU, IM) was injected.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Reproductive Health Research Center, Tehran University of Medical Sciences
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran Univercity of Medical Sciences
Full name of responsible person
Dr Ashraf Moini
Street address
Reproductive Health Research Center, Emam Hospital, Keshavarz Blvd.
City
Tehran
Grant name
طرح های تحقیقاتی
Grant code / Reference number
007
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran Univercity 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, Tehran University of Medical Sciences
Full name of responsible person
Dr Mina Jafarabadi
Position
Assistant professor
Other areas of specialty/work
Street address
Emam hospitel, Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6658 1616
Fax
Email
jafarabadi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Reproductive Health Research Center, Tehran University of Medical Sciences
Full name of responsible person
Dr Mina Jafarabadi
Position
Assistant professor
Other areas of specialty/work
Street address
Emam Hospital, Keshavarz Blvd.
City
Tehran
Postal code
Phone
+98 21 6658 1616
Fax
Email
jafarabadi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)