GnRH agonist protocol prevents premature ovulation and early corpus luteum. The disadvantages are taking high doses and prolonged stimulation of the ovaries to respond better that the eggs are smaller and lower quality recycled. Recently, GnRH antagonists have been used in the middle of the cycle to prevent premature LH surge in the early follicular phase and decreased during ovarian stimulation. In this study, the effect of GnRH antagonists is compared with the long protocol GnRH agonists in patients with poor ovarian response. 100 infertile patients selected with inclusion criteria (number of oocytes recovered in less than 5 ...) and exclusion criteria (presence of chronic diseases ...), they were randomly divided into two groups: GnRH antagonists and GnRH agonists.
GnRH agonist group, use of oral LD on cycle's days 2-3 for 14-21 days, as they will consume in Cycle days 21 Busereline 500 μg (Superfact) subcutaneously. After down regulation, stimulation with HMG is started and continued until at least two follicles with a diameter over mm 18. Busereline will continue daily until HCG (IU 1000) injections. Antagonist group GnRH, when the follicle diameter mm 10 Cetrorelix 0.25 mg subcutaneous injection start and continue would be to inject Day HCG. Fourteen days after oocyte retrival a quantitative serum value of BHCG was obtained, with a result of >10 UI/L being considered positive. Pregnancy is confirmed by the presence of gestational sac in ultrasound 7-6 weeks.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201302271760N21
Registration date:2013-08-28, 1392/06/06
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-08-28, 1392/06/06
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
2013-03-20, 1391/12/30
Expected recruitment end date
2013-10-22, 1392/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of GnRH Antagonist versus GnRH Agonist Protocol on ART outcomes in Poor ovarian Responders
Public title
Effects of GnRH Antagonist versus GnRH Agonist Protocol on ART outcomes in Poor ovarian Responders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women who underwent IVF process and poor ovarian response; The number of oocytes recovered in less than 5; Serum estradiol levels on the day of HCG injection is less than pg / ml 600; Serum FSH levels in Male than 3 mIU / ml 12; Has over 37 years of age; Cessation of ovarian cycles due to poor response.
Exclusion criteria:
Chronic diseases; Diabetes; Any endocrine disease; Submucosal polyps; Leiomyoma and uterine septum.
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:
100
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
Ganjafroz Avenue, Babol University of Medical sciences
City
Babol
Postal code
Approval date
2013-02-05, 1391/11/17
Ethics committee reference number
200/30/ژ-پ
Health conditions studied
1
Description of health condition studied
Poor ovarian Responders
ICD-10 code
E28.8
ICD-10 code description
Other ovarian dysfunction
Primary outcomes
1
Description
Pregnancy
Timepoint
7-6 weeks to see the gestational sac
Method of measurement
Ultrasound
Secondary outcomes
1
Description
Endometrial thickness
Timepoint
Day of HCG injection
Method of measurement
Ultrasound
2
Description
Estradiol levels
Timepoint
Day of HCG injection
Method of measurement
Ultrasound
3
Description
The number of oocytes recovered
Timepoint
Day puncture
Method of measurement
Laboratory
4
Description
The duration of ovarian stimulation
Timepoint
Duration of drug use
Method of measurement
Clinical
5
Description
No. of fertilized oocytes
Timepoint
Day of embryo transfer
Method of measurement
Laboratory
6
Description
The amount of transferred embryos
Timepoint
Day of embryo transfer
Method of measurement
Laboratory
7
Description
The number of canceled cycles
Timepoint
Before embryo transfer
Method of measurement
Clinical
8
Description
Pregnancy than to transfer
Timepoint
16 days after embryo transfer
Method of measurement
Laboratory
9
Description
The incidence of ovarian hyperstimulation syndrome (OHSS)
Timepoint
After puncture
Method of measurement
Clinical & Laboratory
10
Description
The total amount of FSH
Timepoint
48 hours before puncture
Method of measurement
Laboratory
Intervention groups
1
Description
Intervention group:
Agonist (3-2 days after onset of LD cycles lasting 21-14 days, take one tablet daily for 21 days and the cycle Busereline 500 μg (Super facts) will subcutaneously. Later down regulation, stimulation with HMG begin until at least follicle diameters exceeding 2 mm 18 will continue. supermodel facts will continue daily until IU 1000 HCG injection)
Category
Treatment - Drugs
2
Description
Control group:
Antagonist (GnRH when the follicle diameter 10mm, reach to daily injections of HCG, Cetrorelix 0.25 mg subcutaneously daily will)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Fatemehzahra Fertility & reproductive Health Reseach Center
Full name of responsible person
Samaneh Niksimaei
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
Ganjafroz Avenue, Babol University of Medical Sciences, Vice Chancellor for Research and Technology
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
Phone
+98 11 1227 4881
Fax
+98 11 1227 4880
Email
ngh_pa@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fatemehzahra Infertility & reproductive Health Reseach Center
Full name of responsible person
Dr. Mahtab Zeinalzadeh
Position
Gynecologist
Other areas of specialty/work
Street address
Fatemehzahra Infertility & reproductive Health Reseach Center, Noshirvani street
City
Babol
Postal code
Phone
+98 11 1227 4881
Fax
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
City
Babol
Postal code
Phone
00
Fax
Email
ngh_pa@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)