The aim of this study is estrogen priming effect on antagonist cycles in poor responder patients. The study included 106 women 19 to 42 years old with low ovarian reserve who were referred to Al-Zahra infertility clinic. Exclusion criteria are those who do not respond or have a cycle of follicle has been canceled. In this study, the number of follicles developed the number and quality of oocytes and the resulting embryos, endometrial thickness, chemical and clinical pregnancy rate and the number of embryos obtained will be examined. Patients were randomly divided into two groups; 53 patients in control and 53 in the control group. In the intervention group in the 21day of cycle before IVF 2 mg Estradiol ValerateWill start daily and will continue until the second day of cycles. From the second day of cycles with HCG and FSH ovarian stimulation cycles carried out and then on the eighth day (follicle maturation to 12 to 14mm) GNRH antagonist will start and will continue to inject HCG. After seeing at least 2 follicles with dimensions 18mm and above, oocytes from the ovary by transvaginal ultrasound will be taken. After culturing the embryo and grading, the embryo is transferred into the uterus. The control group also entered the treatment cycle with antagonist and gonadotropin with the same conditions only without estrogen priming effect.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201602075942N3
Registration date:2016-04-26, 1395/02/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-26, 1395/02/07
Registrant information
Name
Aliye Ghasemzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3553 9160
Email address
gasemzadeha@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research, Tabriz University of Medical Sciences
Expected recruitment start date
2016-04-16, 1395/01/28
Expected recruitment end date
2017-06-20, 1396/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Estrogen priming effect on antagonist cycles in poor responded patient
Public title
Estrogen priming effect on antagonist cycles in poor responded patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women 19 to 42 years old with low ovarian reserve; Women who have not responded to treatment with short antagonist protocol and gonadotropin or the number of oocytes has been equal to or less than 3.
Exclusion criteria:
who do not respond to treatment or have a cycle of follicle has been canceled; People who have certain diseases like hypothyroidism or hyper prolactin; If patients have complications such as embolism and contraindications to estrogen
Age
From 19 years old to 42 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients divided into two groups of 53 people with table of random numbers
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Ethics Committee Of Tabriz University Of Medical Sciences; Third Floor, Central Building of Number2, Golgasht Street
City
Tabriz
Postal code
Approval date
2016-02-04, 1394/11/15
Ethics committee reference number
TBZMED.REC.1394.1003
Health conditions studied
1
Description of health condition studied
Female infertility
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
The number of mature follicles
Timepoint
14 day of menstrual cycle.
Method of measurement
Ultrasound
2
Description
Oocytes and embryos obtained count
Timepoint
14 day of menstrual cycle.
Method of measurement
Ultrasound
Secondary outcomes
1
Description
Chemical and clinical pregnancy rate
Timepoint
After the delay period
Method of measurement
Tests and ultrasound
2
Description
The resulting embryo count
Timepoint
A month after a positive pregnancy test
Method of measurement
Ultrasound
Intervention groups
1
Description
Intervention group: From 21 days of cycle before the IVF , will be start oral estradiol valerate with 2 mg daily and will continue to the next cycle until the second day of the next cycle.
ovarian stimulation takes place with HMG and of second day. And then on the eighth day that follicle size was the size of 14 to 12 mm . Gonadotropin-releasing hormone will start.
Category
Treatment - Drugs
2
Description
Control group: The control group also entered the antagonist and the gonadotropin treatment cycle , without treatment with estradiol.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Dr.Aliyeh Ghasemzadeh
Street address
Alzahra Hospital, South Artesh Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology University of medical sciences
Full name of responsible person
Dr.Alireza Rashidi
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
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 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
Tabriz University of medical Sciences
Full name of responsible person
Dr.Aliyeh Ghasemzadeh
Position
Associate Professor of Obstetrics Gynecology
Other areas of specialty/work
Street address
Tabriz University of medical Sciences, Golgasht Street
City
Tabriz
Postal code
Phone
00
Fax
Email
lahroudin@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Aliyeh Ghasemzadeh
Position
Associate Professor of Obstetrics Gynecology
Other areas of specialty/work
Street address
Tabriz University of medical sciences, Golgasht Street
City
Tabriz
Postal code
Phone
+98 41 3553 9161
Fax
Email
lahroudin@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Dr.Aliyeh Ghasemzadeh
Position
Associate Professor of Obstetrics Gynecology
Other areas of specialty/work
Street address
Tabriz University Of Medical Sciences, Golgasht Street
City
Tabriz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)