Comparsion of luteal estradiol administration during GnRH antagonist protocol versus microdose GnRH agonist protocol for patients with a history of poor IVF out come
The goal of treatment for poor responders is to synchronize follicular growth and using estradiol before starting gonadotropin stimulation decrease antral follicle heterogeneity. The study is designed as a prospective randomized clinical trial in Yazd research and clinical center for infertility between March 2011 to March 2012.110 patients with poor ovarian response in previous IVF cycle randomly stimulated with luteal estradiol protocol (interventional group) or micro dose protocol (control group).Inclusion criteria: history of poor response to stimulation (<3 dominant follicles or estradiol <500pg/ml), basal FSH level>10 mIU/ml. Exclusion criteria: endometriosis. 55 women in interventional group receive 2 mg estradiol twice a day is started on luteal day 21 and Subsequently stimulation is initiated with gonadotropin in cycle day 2 and 0.25 mg cetrorelix is administrated daily when at least one follicle reach 13-14 mm and continue until the day of hCG injection. Women In control group (n=55) is received Buserelin 50 μg twice/day in cycle day 2 and after two days gonadotropin stimulation is started. Buserelin continue until the day of HCG injection. In both groups 10000 IU HCG is administered IM when at least two follicles reach >17 mm, followed 36 hours later by oocyte retrieval. Embryos are transferred on the third day after retrieval. Clinical pregnancy, number of oocyte ‚duration of stimulation and total dose of gonadotropin is compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108044339N8
Registration date:2011-09-15, 1390/06/24
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2011-09-15, 1390/06/24
Registrant information
Name
Elham Rahmani
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77125265914
Email address
rahmani@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
مرکز تحقیقاتی و درمانی ناباروری یزد
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparsion of luteal estradiol administration during GnRH antagonist protocol versus microdose GnRH agonist protocol for patients with a history of poor IVF out come
Public title
estradiol administration for patients with a history of poor IVFresponse
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: history of poor response to stimulation (<3 dominant follicles or estradiol <500pg/ml), basal FSH level>10 mIU/ml,antral follicle count <5.
Exclusion criteria: endometriosis,only one ovary, endocrine or metabolic disorder.
Age
From 20 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
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
Yazd research and clinical center for infertility
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Postal code
8916877391
Approval date
2011-06-20, 1390/03/30
Ethics committee reference number
933
Health conditions studied
1
Description of health condition studied
female infertility
ICD-10 code
N97
ICD-10 code description
female infertility
Primary outcomes
1
Description
the number of oocyte retrival
Timepoint
the day of puncture
Method of measurement
counting by microscope
Secondary outcomes
1
Description
chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
serum BHCG
Intervention groups
1
Description
Women in interventional group (n=55) receive 2 mg estradiol twice a day is started on luteal day 21 and Subsequently stimulation is initiated with gonadotropin in cycle day 2 and 0.25 mg cetrorelix is administrated daily when at least one follicle reach 13-14 mm and continue until the day of hCG injection. 10000 IU hCG is administered IM when at least two follicles reach >17 mm, followed 36 hours later by oocyte retrieval. Embryos are transferred on the third day after retrieval.
Category
Treatment - Drugs
2
Description
women In control group (n=55) is received Buserelin 50 μg twice/day in cycle day 2 and after two days gonadotropin stimulation is started. Buserelin continue until the day of hCG injection. 10000 IU hCG is administered IM when at least two follicles reach >17 mm, followed 36 hours later by oocyte retrieval. Embryos are transferred on the third day after retrieval.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd research and clinical center for infertility
Full name of responsible person
Dr Robab Davar
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Dr. Robab Davar
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd research and clinical center for infertility
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
Yazd research and clinical center for infertility
Full name of responsible person
Dr Mozhgan Rahsepar
Position
Obestetrics and Gynecologist,Student of fellowship
Other areas of specialty/work
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
drrahsepar@hotmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Dr Robab Davar
Position
Obestetrics and Gynecologist, fellowship of infertility
Other areas of specialty/work
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
r_davar@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)