In this study we compare routine Gonadotropin releasing hormone (GnRH) agonist long protocol with Luteal phase Estradiol. 60 selected patients (poor responders referred to the Infertility Center of Fatemeh-Zahra) according to inclusion criteria (those with fewer than 5 oocytes number …) and exclusion criteria (patient who are not satisfied to entry the study) are divided in two groups. In group1 GnRH agonist begin at 21th day of menstruation cycle and then Administration of Gonadotropin will begin at 3th day of next cycle and continue until the day of HCG injection. Group2 will use Estradiol 2mg twice a day form 21th day and continue until 3th day of Gonadotropin administration. Poor responder: Oocyte number fewer 5, Age>37, basic FSH>12, previous cancel cycle. All patients will give Vaginal ultrasound in menstruation period and then both groups will begin using of oral contraceptive LD and continue until 21th day of cycle. Then group1 and group2 protocol performs. When the largest follicle reached the 18mm a single 10000 IU of HCG will administrate. Trans-vaginal oocyte retrieval will be performed 35 hours later. 2-3 day later embryo transfer will be done.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901311760N4
Registration date:2011-01-06, 1389/10/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-06, 1389/10/16
Registrant information
Name
Nargess Gholizadeh Pasha
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center, Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 2282
Email address
zahra@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2010-11-22, 1389/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To compare outcomes between a standard protocol and a luteal phase estradiol in infertile patients with poor responders
Public title
To compare outcomes between a standard protocol and a luteal phase estradiol in infertile patients with poor responders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Infertile patents with poor ovarian response, Oocytes number<5 or age>37, Basal FSH>12 Or canceled the previous cycle. Exclusion criteria: Patients who do not consent to enter the study.
Age
From 37 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
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
The ethics committee of Babol University of Medical sciences
Street address
Gangafroz Avenue, Babol University of Medical sciences
City
Babol
Postal code
4717641367
Approval date
2010-07-12, 1389/04/21
Ethics committee reference number
1014
Health conditions studied
1
Description of health condition studied
poor responder patients in ART(Assisted Reproductive Technology)
ICD-10 code
E28.8
ICD-10 code description
Other ovarian dysfunction
Primary outcomes
1
Description
Number of oocytes
Timepoint
puncher day
Method of measurement
Counted by the laboratory
2
Description
Total fetus
Timepoint
2 days after puncher
Method of measurement
Counted by the laboratory
Secondary outcomes
1
Description
Pregnancy
Timepoint
17 days after embryo transfer
Method of measurement
blood BHCG test
Intervention groups
1
Description
Group 1: oral contraceptive LD; GnRH agonist injection; Gonadotropin injection; HCG injection (10000 IU Im)
Category
Treatment - Drugs
2
Description
Group2: Oral contraceptive LD; CnRH agonists injection; Oral estradiol 2mg, twice a day; Gonadotropin injection; HCG injection (10000 Iu Im)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemehzahra Fertility & reproductive Health Reseach Center
Full name of responsible person
Dr. maryam BaGhori
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center, Noshirvani street
City
Babol
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Babol University of Medical Sciences
Full name of responsible person
Dr. Ali bijani
Street address
Gangafroz Avenue
City
Babol
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 and Technology, Babol 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
Fatemehzahra Fertility & reproductive Health Reseach Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible for Public Affairs of Research Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center, Noshirvani street
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
zahra@mubabol.ac.ir , ngh_pa@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemehzahra Fertility & reproductive Health Reseach Center
Full name of responsible person
Dr. Matab Zeinalzadeh
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center, Noshirvani street
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
zeinalmahtab@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Fatemehzahra Infertility Reproductive Health Research Center
Full name of responsible person
Nargess Gholizadeh Pasha
Position
M.A/Responsible for Public Affairs of Research Center
Other areas of specialty/work
Street address
Fatemehzahra Fertility & reproductive Health Reseach Center - noshirvani steert
City
Babol
Postal code
4719173716
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
zahra@mubabol.ac.ir , ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)