This study aimed ist comparing two long-acting antagonist regimen (Alvnva) with or without HMG In this study. 200 infertile patients based on 2011 ESHRE Criteria
Characteristics of patients with poor ovarian response and without any disease were randomly divided into two groups according to a random numbers table. Antagonists are prescribed in both groups for ovarian stimulation.In group 1 ( intervention group ) a dose of 150 mg corrifollitropin alfa on the third day of the menstrual cycle are prescribed then on the seventh day after cycles , antagonist drug, Orgalutran, .5 mg daily wii be administerated. Control group in the third day of the menstrual cycle. ,Corrifolitropin alfa 150 mcg dose group received and the only recombinant FSH during the first seven days of daily monitoring cycle will receive. In both groups IN Day 7 of ovarian stimulation will be underwent transvaginal ultrasound by a physician who specializes in obstetrics and gynecology that do not have any knowledge about groups A and B., Then in both groups number of oocytes, number of embryos, and stimulated during pregnancy and abortion rates will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201404065181N13
Registration date:2014-06-02, 1393/03/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-06-02, 1393/03/12
Registrant information
Name
Batool Rashidi
Name of organization / entity
Vali E Asr Reproductive Health Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6693 9320
Email address
bhrashidi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical sciences ,Vice Chancellor for research
Expected recruitment start date
2014-12-20, 1393/09/29
Expected recruitment end date
2016-05-30, 1395/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of using of recombinant Fsh long acting with or without hMG in IVf/ICSI cycles
Public title
Comparison of using of recombinant Fsh long time with or without hMG in IVf/ICSI cycles
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:All patients agreed upon ESHRE Criteria 2011 ,advanced maternal age( >40 years )؛ previous poor ovarian respond (POR)؛ abnormal ovarian reserve Test ( AFC=5-7, AMH=0.5-1.1)are enrolled.
Exclusion Criteria:Cigaret user; history of ovarian cyst or surjeri in ovary;primary sensitivity to Cinal Or Gonal-F ; Tumors depended to Sex in reproductive systhem ;Adrenal failure or oncontrlod Thyroid;andometriosis;couple chromosomal difficulties;ovulatory dysfunction ( hypogonadic or hypergonadic infertility , hyperprolactinemia,thyroid disease, neoplastic ovary and adrenal,Kushing syndrome).
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical sciences ,Vice Chancellor for research
Street address
Tehran University Building,Ghods Street,Keshavarz Blvd
City
Tehran
Postal code
Approval date
2014-04-30, 1393/02/10
Ethics committee reference number
93-01-39-25430
Health conditions studied
1
Description of health condition studied
Female infertility associated with anovulation
ICD-10 code
N97.0
ICD-10 code description
Female infertility associated with anovulation
Primary outcomes
1
Description
Mature oocyte
Timepoint
time of getting oocyte
Method of measurement
microscopic assay
2
Description
number of fetus
Timepoint
two days after getting of oocytes
Method of measurement
microscopic assay by embryologists
Secondary outcomes
1
Description
days of ovulation induction
Timepoint
Medication at the time of ovulation induction
Method of measurement
Patient records
2
Description
abortion
Timepoint
two weeks after embryo transfer
Method of measurement
transvaginal sonography and blood test
3
Description
pregnancy
Timepoint
two weeks after embryo transfer
Method of measurement
transvaginal sonography and blood test
Intervention groups
1
Description
Control group: A dose of 150 mcg corrifolitropin alfa received on the third day of the menstrual cycle , Antagonist drug Orgalutran, 5 mg is given on the seventh day.
Then, during the monitoring cycle of seven days, if needed, will receive only the daily recombinant FSH. Ovarian response is followed by vaginal ultrasound, when at least one follicle greater than 18 mm and there were at least three follicles larger than 14-15 mm, HCG Pregnyl) will be injected with a dose of 10,000 units.
Category
Treatment - Drugs
2
Description
Intervention group: A dose of 150 mcg corrifolitropin alfa is administrated on the third day of the menstrual cycle. Antagonist drug Orgalutran, 5 mg is given on the seventh day.
Then on the seventh day after the cycle if needed, hMG will administrated. Ovarian response is followed by vaginal ultrasound, when at least one follicle greater than 18 mm and there were at least three follicles larger than 14-15 mm, HCG Pregnyl) will be injected with a dose of 10,000 units.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valie Asr infertility Clinic
Full name of responsible person
Dr,Batool Rashidi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vhice chancellor of
Full name of responsible person
DR,KARBAKHSH
Street address
Tehran University Building,Ghods Street,Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?