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Comparsion of effects of Gonadotropin Releasing Hormon Agonists and Antagonists in ART cycles in patients 35 years and older

Protocol summary

Summary
Study included two group of 60 patients of infertile women 35 years old and older who fulfill inclusion criteria (infertility , 35 years old and older, without endocrine problems and hypertension and pcos (polycystic ovarian syndrome) and without any history of pelvic endometriosis or ovarian surgery are studied. patients of group one receives Gonadotropin Releasing Hormone Agonists from 21st day of cycle before of art and at 2nd or 3rd days of next cycle ,after sonography if ovaries are inactive and endometrial thickness is less than 4mm, induction ovulation with external gonadotropins take place. In second group from 2nd or 3rd days of cycle induction ovulation with external gonadotropins take place, after growth of follicles to 14mm (equal to 8th days of cycle) Gonadotropin Releasing Hormone Antagonists starts. At the end two groups are compared for number of follicles which are growth, number of obtained ovum, Estradiol levels, endometrial situation, and duration of stimulation for induction ovulation, pregnancy rate, and abortion rate before 12 weeks of pregnancy, prevalence and severity of OHSS, number of used ampoules of gonadotropins.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201109136626N3
Registration date: 2011-10-16, 1390/07/24
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-10-16, 1390/07/24
Registrant information
Name
Seddighe Abdollahi fard
Name of organization / entity
Tabriz university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 4250
Email address
dr-abdollahi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Women's Reproductive Health Research Center,Tabriz University of Medical Sciences
Expected recruitment start date
2011-09-11, 1390/06/20
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion of effects of Gonadotropin Releasing Hormon Agonists and Antagonists in ART cycles in patients 35 years and older
Public title
Comparsion of effects of Gonadotropin Releasing Hormon Agonists and Antagonists in ART cycles in infertile patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:infertile women older than 35 years who are conditions for art and have not any endocreean desease or hypertantion or polycistic ovarian syndrom(pcos) or history of endometriosis or any surgery of ovarian Exclusion criteria: Infertile women smaller than 35 years old or have any endocreean desease or hypertantion or polycistic ovarian syndrom(pcos) or history of endometriosis or any surgery of ovarian
Age
From 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
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
Tabriz University of Medical Science
Street address
Tabriz University of Medical Science ,Golgasht ave, Azadi ave
City
Tabriz
Postal code
Approval date
2011-09-10, 1390/06/19
Ethics committee reference number
4686 /4/5

Health conditions studied

1

Description of health condition studied
infertility
ICD-10 code
n97
ICD-10 code description
female infertility

Primary outcomes

1

Description
Rate of documented pregnancy
Timepoint
Two mounths after the end of intervention
Method of measurement
Sonography

Secondary outcomes

1

Description
Rate of abortion before 12 weeks of pregnancy
Timepoint
Four mounths after the end of intervention
Method of measurement
Sonography

2

Description
Severity of ovarian hyperstimulation syndrom
Timepoint
During one mounth after the end of intervention
Method of measurement
By examination and sonography

3

Description
Rate of chemical pregnancy
Timepoint
Two weeks after end of intervention
Method of measurement
unit/litter

4

Description
Prevalance of ovarian hyperstimulation syndrom
Timepoint
During one mounth after the end of intervention
Method of measurement
By examination and sonography

5

Description
Number of follicles which are growth
Timepoint
During of intervention(36 hours after hcg injection)
Method of measurement
Sonography

6

Description
Number of the obtiened ovums
Timepoint
During the intervention(36 hours after hcg injection)
Method of measurement
By counting

7

Description
Estradiol levels
Timepoint
During the intervention(day of hcg injection)
Method of measurement
pg/ml

8

Description
Endometrial situation
Timepoint
During the intervention(day of hcg injection)
Method of measurement
Sonography

9

Description
Duration of the stimulation for induction ovulation
Timepoint
During the intervention
Method of measurement
Days

10

Description
Number of the ampuls of gonadotropins used
Timepoint
During the intervention
Method of measurement
By counting

Intervention groups

1

Description
Exogenic gonadotropin Gonal F 75unit IM daily and Monogon 150 unit IM daily both of them at 2th_3th of cycle if ovarians are inactive and endometial thickness is less than 4mm (in both groups)
Category
Treatment - Drugs

2

Description
Gonadotropin Releasing Hormon Agonist (superfact) 0.5 cc subcutaneus daily from 21th day of cycle until diameter of dominant follicle reachs to 18_19mm (in group one)
Category
Treatment - Drugs

3

Description
Gonadotropin Releasing Hormon Antagonist (cetrotide) 3.5mg subcutaneus single dose (in second group)
Category
Treatment - Drugs

4

Description
Human chorionic gonadothropin (hcg)(pregnil)1000 unit IM single dose ,when diameter of dominant follicle reachs 18_19mm
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
AL-Zahra hospital
Full name of responsible person
Street address
Al-zahra hospital,South artesh ave, Bagh shomal crossroad,Tabriz,iran
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Vise chanceller for research, Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht ave, Azadi ave
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
AL-zahra hospital,Tabriz university of medical science
Full name of responsible person
Seddighe Abdollahi
Position
Associate Professor
Other areas of specialty/work
Street address
Al_zahra hospital,Bagh shomal crossroad,South artesh ave,tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
dr-abdollahi@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
AL-zahra hospital,Tabriz university of medical science
Full name of responsible person
Seddighe Abdollahi
Position
Associate Professor
Other areas of specialty/work
Street address
Al_zahra hospital,Bagh shomal crossroad,South artesh ave,tabriz
City
Tabriz
Postal code
Phone
+98 41 1553 9161
Fax
Email
dr-abdollahi@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Neda Zafarbakhsh
Position
MD
Other areas of specialty/work
Street address
Al_zahra hospital,Bagh shomal crossroad,South artesh ave,tabriz
City
Tabriz
Postal code
Phone
+98 914 115 7141
Fax
Email
neda_zafarbakhsh2000@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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