Management of poor responders to ovarian stimulation consists about 9-18% of the patients undergoing IVF and it is one of the most important problems in assisted reproductive techniques (ART). The aim of the present study is to evaluate the effect of addition of growth hormone to antagonist regimen in poor responders in assisted reproductive cycles. One hundred and twenty candidates of assisted reproductive technology referred to Yazd Research and Clinical Center for Infertility who have a history of one or more failed IVF or ICSI cycles with three or fewer retrieved oocytes, are prospectively randomized in two groups. In group I (60 patients), the antagonist regimen and in group II (60 patients), growth hormone 4 IU per day S.Q are added to antagonist protocol until the day of HCG injection. Main outcomes measures are: the number of follicles and oocytes, endometrial thickness, clinical and chemical pregnancy and implantation rates.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107296420N6
Registration date:2011-08-21, 1390/05/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-08-21, 1390/05/30
Registrant information
Name
Maryam Eftekhar
Name of organization / entity
Yazd Research and Clinical Center for Infertility
Country
Iran (Islamic Republic of)
Phone
+98 35182470856
Email address
eftekhar@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2009-01-01, 1387/10/12
Expected recruitment end date
2011-01-01, 1389/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Adjuvant growth hormone therapy in antagonist protocol in poor responders undergoing assisted reproductive technology
Public title
Effect of growth hormone in IVF protocol
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: history of one or more failed in IVF cycles which three or fewer oocytes were been retrieved; serum steradiol’s level in day of HCG injection <500 pg/ml; FSH in day 3 of cycle >10 and age>40 years. Exclusion criteria: Body mass index higher than 30; endocrine or metabolic disorder; endometriosis and severe male factor (azospermia ).
Age
From 18 years old to 45 years old
Gender
Female
Phase
2-3
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
Yazd reserch and clinical center for infertility
Street address
Bouali Ave, Safayeh
City
Yazd
Postal code
Approval date
2011-06-20, 1390/03/30
Ethics committee reference number
932
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
N97
ICD-10 code description
Female infertility
Primary outcomes
1
Description
chemical pregnancy
Timepoint
2 weeks
Method of measurement
serum BHCG
Secondary outcomes
1
Description
number of oocyte
Timepoint
15 days
Method of measurement
numberring
2
Description
number of gonadotropin ampuls
Timepoint
15 days
Method of measurement
numberring
Intervention groups
1
Description
In study group: Patients in group I (growth hormone group) receive daily injection of 4 mg growth hormone from day 21 of previous cycle until the day of hCG injection. Ovarian stimulation is started from second day of menstrual cycle with 300 IU of HMG monitoring by serial vaginal sonography and measurement of serum E2 levels. When dominant follicles reach to 14 mm in mean diameter, 0.25mg/day of GnRH antagonist(cetrotide) is started and continued until the day of hCG injection, when at least two follicles with a mean diameter of 17 mm were observed 10000 IU hCG is injected and oocyte retrieval is done 35 hours later.
Category
Treatment - Drugs
2
Description
In control group: Patients in group II (control group); Ovarian stimulation is started from second day of menstrual cycle with 300 IU of HMG monitoring by serial vaginal sonography and measurement of serum E2 levels is done. When dominant follicles reach to 14 mmin mean diameter, 0.25mg/day of GnRH antagonist (cetrotide , sereno) is started and continued until the day of hCG injection, when at least two follicles with a mean diameter of 17 mm were observed 10000 IU hCG was injected . and oocyte retrieval is done 35 hours later.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd research and clinical center for infertility
Full name of responsible person
Maryam Eftekhar
Street address
Boali Ave., Safayeh
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Dr Abbas Aflatoonian
Street address
Bouali Ave, Safayeh
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 reaserch and clinical center for infertility
Full name of responsible person
Maryam Eftekhar
Position
Assisted professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
yazd Research and Clinical Center for Infertility, Bouali Ave, Safayeh
City
Yazd
Postal code
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
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
maryam Eftekhar
Position
Assisted professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Bouali Ave, Safayeh
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
eftekhar@ssu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Maryam Eftekhar
Position
Assisted professor of Obstetrics and Gynecology
Other areas of specialty/work
Street address
Bouali Ave, Safayeh
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
eftekhar@ssu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)