Protocol summary

Summary
this clinically trial aims at comparing the two standard antagonist protocol with Minimal stimulation using Clomiphen and Gonadotrophin in poor responders based on Blogna criteria .patients are included in this trial that two of three blogna critria would be had.patients with contraindication this drugs are excluded .they are divided in two groups of 49 persons .one group is treated with standard antagonist protocol ,other group is treated with minimal with clomiphen & gonadotrphin protocol .in both groups oocyte count and pregnancy rate is compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015011920351N2
Registration date: 2015-02-05, 1393/11/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-02-05, 1393/11/16
Registrant information
Name
Ensieh Shahrogh Tehraninejad
Name of organization / entity
Tehran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1616
Email address
etehraninejad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University Of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
clinical outcome following stimulation with standard antagonist &minimal stimulation in poor responders .
Public title
effect of clomiphen &gonadotrophine at ovarian stimulation in poor responders .
Purpose
Other
Inclusion/Exclusion criteria
Inclusion critria : IVF candidates; who are considered according to Blogna . exclusion criteria : contraindication of drug usage.
Age
From 14 years old to 15 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 98
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
Street address
Imam Khomeini Hospital . Valiasr Hospital ,Infertility Clinic
City
Tehran
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
Thesis

Health conditions studied

1

Description of health condition studied
poor responders in IVF
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation

Primary outcomes

1

Description
oocyte count .
Timepoint
before stimulation & 4 days & according to tvs ...
Method of measurement
tvs & oocyte count

Secondary outcomes

1

Description
pregnancy Rate
Timepoint
14 days After E mbrio Transfer
Method of measurement
Serum B-hCG

Intervention groups

1

Description
in GnRH antagonist /clomiphen group(study) , clomiphen 100 mg oral is started from day 2 until 6 day of cycle & gonadotropin with 150 IU daily SC is started from day 5 & when at least one follicle >14 is observed , 0.25 mg cetrotide SC daily is started & continued until follicle 18 mm is observed , then hCG 10000 IU is administrated IM , oocyte is retrivied 34-36 after administeration of hCG . in this group ,retrieval is performed 34-36 h after hCG injection .
Category
Treatment - Drugs

2

Description
n control group ,gonadotrophin is started from day 2 cycle at least 300 IU SC , when at least one follicle >14 is observed , 0.25 mg cetrotide SC daily is started & countiniued until follicle 18 mm is observed then hCG 10000 IU is administrated IM , oocyte is retrivied 34-36 hours after hCG injection.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital , Valiasr Hospital ,Infertility Clinic
Full name of responsible person
Shamim Pilehvari
Street address
Imam Khomeini Hospital , Valiasr Hospital ,Infertility Clinic
City
TEHRAN

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor For Research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Masoud Younesian
Street address
Keshavarz Blvd., Qods, TUMS Central Building
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research, 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
Tehran University Of Medical Sciences
Full name of responsible person
Shamim Pilehvari
Position
Fellow Infertillity Asistant
Other areas of specialty/work
Street address
Imam Khomeini Hospital Complex,Valiasr Hospital ,Infertility Clinic tilit clinic
City
Tehran
Postal code
Phone
+98 21 6658 1616
Fax
Email
sh.pilehvari@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University Of Medical Sciences
Full name of responsible person
Ensieh Shahrogh Tehraninejad
Position
Infertillity Lecturer
Other areas of specialty/work
Street address
Imam Khomeini Hospital ,Valiasr Hospital ,Infertillity Clinic
City
Tehran
Postal code
Phone
+98 21 6658 1616
Fax
Email
etehrani@yahoo.cometehraninejad@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medica l Sciences
Full name of responsible person
Shamim Pilehvari
Position
Fellow Infertility Assistent
Other areas of specialty/work
Street address
Imam Khomeini Hospital Complex , Valiasr H,Infertility Clinic clinic
City
Tehran
Postal code
Phone
+98 21 6658 1616
Fax
Email
sh.pilehvari@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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