Protocol summary

Summary
Objective: to compare GnRH antagonist and agonist protocols regarding the outcome and rate of OHSS. Subjects: women who were referred to the infertility center of Beheshti hospital, Isfahan, Iran, for ART . 136 patients were randomly allocated to 2 groups: 67 patients were treated with GnRH agonist, 69 patients were treated with GnRH antagonist. Inclusion criteria: age ≤35, FSH level ≤10 IU/liter. Exclusion criteria: hyperprolactinemia, thyroid dysfunction, uterine abnormality, severe endometriosis. Group A, a daily dose of Buserelin 500 µg given SC and commenced 21st day of cycle, and vaginal ultrasonography continued onward until estradiol on the 2st day of cycle. Group B, GnRH antagonist was administered. Ovarian stimulation was started on the 2nd day of the cycle by SC injection of 75 IU of FSH daily. On the 6th day of stimulation, 0.25 mg Cetrorelix was initiated. Based on the ovarian response detected by ultrasonography, gonadotropin dose was adjusted in both groups. Administration of Buserelin and Cetrorelix was continued until the time of HCG injection. When at least 3 follicles with a mean diameter of 18 mm were developed, HCG 10,000 IU was injected IM. At this stage, endometrial thickness was studied Trans vaginal ultrasonographically, and after 36 hours, oocyte retrieval was performed. After IVF or ICSI, Cyclogest 800 mg was prescribed daily to provide luteal phase support and continued till the activity of FHR was confirmed TVS. Sixteen days after the oocyte retrieval, serum HCG level was checked to determine chemical pregnancy. TVS was carried out for clinical determination of pregnancy.

General information

Acronym
GnRH
IRCT registration information
IRCT registration number: IRCT201205309910N1
Registration date: 2012-06-24, 1391/04/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-06-24, 1391/04/04
Registrant information
Name
Setare Nasiri Zeydi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1651 2267
Email address
setare_n99@yahoo.com
Recruitment status
Recruitment complete
Funding source
Private
Expected recruitment start date
2011-01-22, 1389/11/02
Expected recruitment end date
2012-02-12, 1390/11/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of outcome of assessment reproduction treatment and prevention of ovarian hyper stimulation syndrome in GnRH agonist protocol compared to GnRH antagonist protocol
Public title
Comparing two different drug methods for infertility treatment by assisted reproduction techniques (ARTs)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: undergoing assisted reproduction techniques (ARTs) for the first time, age ≤35years and serum FSH level ≤10 IU/liter. Exclusion criteria: women with the previous history of IVF or ICSI; patients who had hyperprolactinemia, thyroid dysfunction, uterine abnormality, severe endometriosis and secondary infertility.
Age
To 35 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 136
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezar jerib street
City
Isfahan
Postal code
Approval date
2011-11-09, 1390/08/18
Ethics committee reference number
390428

Health conditions studied

1

Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility

Primary outcomes

1

Description
Ovarian hyperstimulation syndrome
Timepoint
10 days after HCG injection and during primary Trimester
Method of measurement
as presence of enlarged ovarian cysts more than 12 by 12 cm, ascites, pleural and/or pericardial effusion, electrolyte imbalance ,hypovolemia, and hypovolemic shock

2

Description
Fertility
Timepoint
after primary Trimester
Method of measurement
ultrasonography

Secondary outcomes

1

Description
number of retrieved oocytes
Timepoint
2 weeks after intervention
Method of measurement
number of retrieved oocytes in retrieval day

Intervention groups

1

Description
Group A: a daily dose of Buserelin 500 µg given SC and commenced 21th day of cycle, and vaginal ultrasonography continued onward until estradiol on the 2nd day of cycle.
Category
Treatment - Drugs

2

Description
Group B: GnRH antagonist was administered. Ovarian stimulation was started on the 2nd day of the cycle by SC injection of 75 IU of FSH daily. On the 6th day of stimulation, 0.25 mg Cetrorelix was initiated. Based on the ovarian response detected by ultrasonography, gonadotropin dose was adjusted in both groups. Administration of Buserelin and Cetrorelix was continued until the time of HCG injection. When at least 3 follicles with a mean diameter of 18 mm were developed, HCG 10,000 IU was injected IM. At this stage, endometrial thickness was studied Trans vaginal ultrasonographically, and after 36 hours, oocyte retrieval was performed. After IVF or ICSI, Cyclogest 800 mg was prescribed daily to provide luteal phase support and continued till the activity of FHR was confirmed TVS.16days after the oocyte retrieval, serum HCG level was checked to determine chemical pregnancy. TVS was carried out for clinical determination of pregnancy
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Infertility center of Beheshti hospital
Full name of responsible person
Street address
Beheshti hospital, Isfahan
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr.Taleb azarm
Street address
Isfahan University of Medical Sciences, Hezar jerib st.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Setare Nasiri Zeydi
Position
Obstetric and gynecology resident
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 911 255 6829
Fax
Email
setare_n99@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Setare Nasiri Zeydi
Position
obstetric and gynecology resident
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 911 255 6829
Fax
Email
setare_n99@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Masoumeh Hashemi
Position
Phd student in Reproductive Health
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
Fax
Email
mhashemi_ob@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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