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Comparision of ART(IVF or ICSI) outcome in two different induction ovulation protocols: Gonal-F versus Fostimon, in infertile patients with PCOD, referring to Valiasr hospital during 1387-1388

Protocol summary

Summary
This randomized clinical trial study was done on 160 PCOS patients and infertile candidates ART (Assisted Reproduction Technique) in the infertility clinic of Vali-Asr Hospital during the years 1387 to 1388 after obtaining the consent letter.Inclusion criteria: age(20-35y), having at least 2 PCO criteria (oligo or anovulation, oligo or amenorrhea, hyperandrogenemia, hirsutism, volum of ovary>10ml, poly cystic ovaries), normal karyotype of couples. Exclusion criteria: age>35 or<20y, abnormal karyotype, other diseases causing anovulation(hypo or hyper gonadotropic hypogonadism, Cushing, hyperprolactinemia.), other causes of infertility, not having PCO criteria, history of poor response to gonadotropin induction. Patients were randomly divided into two 80-member groups. Group A received 150 units of recombinant FSH (Gonal-F ) daily& group B, 150 units of urinary FSH (Fostimon). Patients were evaluated with sonography in order to measure the size of follicles & adjust gonadotropin dose. Demographic data and quantitative variables studied including (follicles, obtained immature oocytes, oocytes, the embryos transferred, clinical &chemical pregnancy) were inserted in questionnaire and evaluated.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138901193636N1
Registration date: 2010-04-08, 1389/01/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-04-08, 1389/01/19
Registrant information
Name
Shahrzad Sheikh Hassani
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6619 2366
Email address
sheikhhasani86@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2008-03-20, 1387/01/01
Expected recruitment end date
2010-03-20, 1388/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of ART(IVF or ICSI) outcome in two different induction ovulation protocols: Gonal-F versus Fostimon, in infertile patients with PCOD, referring to Valiasr hospital during 1387-1388
Public title
Comparision of ART(IVF or ICSI) outcome in two different induction ovulation protocols: Gonal-F versus Fostimon, in infertile patients with PCOD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age(20-35y), having at least 2 PCO criteria (Oligo or anovulation, oligomenorrhea or amenorrhea, hyperandrogenemia, hirsutism, volum of ovary>10ml, poly cystic ovaries), normal karyotype of couples, Exclusion criteria: age>35 or<20y, abnormal karyotype, other diseases causing anovulation(hypo or hyper gonadotropic hypogonadism, Cushing, hyperprolactinemia.), other causes of infertility, not having PCO criteria, history of poor response to gonadotropin induction.
Age
From 20 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 160
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
Tehran University Of Medical Sciences, Ethics committee
Street address
Poorsina Avenu
City
Tehran
Postal code
Approval date
2008-06-06, 1387/03/17
Ethics committee reference number
835

Health conditions studied

1

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

2

Description of health condition studied
polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
polycystic ovarian syndrome

Primary outcomes

1

Description
rate of clinical pregnancy
Timepoint
2 weeks after positive Bhcg
Method of measurement
sonography

2

Description
rate of chemical pregnancy
Timepoint
2 weeks after emberyo transfer
Method of measurement
serum bhcg

Secondary outcomes

1

Description
Rate of abortion
Timepoint
Every 2-4 weeks, based on patients' signs
Method of measurement
sonography

2

Description
Ongoing pregnancy
Timepoint
12 weeks after positive BHCG
Method of measurement
sonography

3

Description
Numbers of follicles >18mm
Timepoint
2-3 days after gonadotropin injection
Method of measurement
sonography

4

Description
Numbers of oocyts
Timepoint
in day of pick up
Method of measurement
Counting picked up oocyts

5

Description
Numbers of embryos
Timepoint
day of embryos transfer, 3 days after pick up
Method of measurement
counting embryos

6

Description
Endometrial thickness
Timepoint
At the day of HCG (Amp.) injection
Method of measurement
sonography

7

Description
Total numbers of gonadotropin ampoule administered
Timepoint
At final cycle
Method of measurement
Counting of ampoule administered

8

Description
Quality of embryo
Timepoint
3 days after pick up
Method of measurement
by embryologist (grad A, B, C)

9

Description
Numbers of embryos transferred
Timepoint
day of embryo transrfer
Method of measurement
counting of embryos transferred

Intervention groups

1

Description
Group A, Gonl-F injection
Category
Treatment - Drugs

2

Description
Group B, Fostimon injection
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Valiasr hospital, infertility center
Full name of responsible person
Maryam Baghery, Shahrzad Sheikhhasani
Street address
Bagherkhan Aven. Emam Khomeini hospital
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
khorrami
Street address
Poorsina Aven.
City
Tehran
Grant name
پايان نامه
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Emam khomeini hospital
Full name of responsible person
Shahrzad. Sheikhhasani
Position
resident of obstetrics & gynaecology
Other areas of specialty/work
Street address
Bagherkhn Aven.
City
Tehran
Postal code
Phone
+98 21 6119 2365
Fax
+98 21 6119 2366
Email
dr_sh1356@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran Univrsity OF Medical Sciences
Full name of responsible person
Dr.Farnaz Sohrabvand
Position
specialist in Ob.Gyn. & infertility
Other areas of specialty/work
Street address
Bagherkhan Aven.Emam hospital
City
Tehran
Postal code
Phone
+98 21 6119 2366
Fax
+98 21 6119 2365
Email
Fsohrabvand@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University Of Medical Sciences, Emam khomeini hospital
Full name of responsible person
Shahrzad Sheikhhasani
Position
resident of Ob. Gyn
Other areas of specialty/work
Street address
Bagherkhan Aven.
City
Tehran
Postal code
Phone
+98 21 6119 2366
Fax
+98 21 6119 2365
Email
dr_sh1356@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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