Comparing effect of agonist & antagonist drugs of GnRh in ovulation stimulation in infertile couples with male factor (abnormalities of sperm production and sperm function and obstructions in the ductal system)
To compare the effect of agonist & antagonist drugs of GnRh in ovulation stimulation in infertile couples with male factor (abnormalities of sperm production and sperm function obstructions in the ductal system). We recruited 42 persons as control group and 42 persons as intervention group. Inclusion criteria: 18-40 years old ladies, having no risk factor for infertility with infertile spouse. Intervention: injecting Gonal-F ampoule, from the 3rd day of cycle and then injecting Cetrotide ampoule, 0.25 mg daily till formation of at least two follicles 17-18 cm and several follicles 14-16 cm through testing by serial ultrasonography; then taking follicle through injecting HCG (human chorionic gonadotrop), after 36 hours. Primary outcome: number of dominant follicle; number of punctured ovule; number of eggs on the third day; number of clinical pregnancy; incidence of OHSS; therapy duration and cost.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111058010N1
Registration date:2012-02-13, 1390/11/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-13, 1390/11/24
Registrant information
Name
Maryam Hedayat
Name of organization / entity
Hamedan University of Medical Sciences & Health Services
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0572
Email address
maryam.hedayat@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy, Hamedan University of Medical Sciences
Expected recruitment start date
2010-07-06, 1389/04/15
Expected recruitment end date
2012-02-18, 1390/11/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing effect of agonist & antagonist drugs of GnRh in ovulation stimulation in infertile couples with male factor (abnormalities of sperm production and sperm function and obstructions in the ductal system)
Public title
Comparing effect of agonist & antagonist drugs of Gonadotropin Releasing Hormone (GnRh) in ovulation stimulation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 18-40 years old ladies, having no risk factor for infertility, with infertile spouse. Exclusion criteria: none.
Age
From 18 years old to 40 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
84
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
Hamedan University of Medical Sciences
Street address
Hamedan University Of Medical Sciences & Health Services
City
Hamedan
Postal code
Approval date
2011-11-19, 1390/08/28
Ethics committee reference number
2860/35/16/پ/د
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N46
ICD-10 code description
Male infertility
2
Description of health condition studied
Infertility
ICD-10 code
N50.0
ICD-10 code description
Atrophy of testis
3
Description of health condition studied
infertility
ICD-10 code
N50.8
ICD-10 code description
Other specified disorders of male genital organs
4
Description of health condition studied
infertility
ICD-10 code
N97.4
ICD-10 code description
Female infertility associated with male factors
Primary outcomes
1
Description
Number of dominant follicle
Timepoint
The day in which there are seen at least 2 follicles with the sizes 17-18 cm
Method of measurement
Repeating sonography every 2 days from the date of starting induction till ripping follicle having the foregoing particulars
2
Description
Number of eggs in third day of fertilization
Timepoint
Third day of fertilization
Method of measurement
counting
3
Description
Number of positive clinical pregnancy
Timepoint
16 day after embryo transfer
Method of measurement
laboratory
4
Description
Number of induction days
Timepoint
From the date of starting till injection of HCG ampoule
Method of measurement
counting
5
Description
Cost of drugs
Timepoint
From the date of starting till injection of HCG ampoule
Method of measurement
total drug costs
6
Description
Number of punctured ovum
Timepoint
Immediately after puncture
Method of measurement
counting
Secondary outcomes
1
Description
Incidence of OHSS
Timepoint
3-5 day after puncture
Method of measurement
sign- sonography-lab
Intervention groups
1
Description
Control group: starting Buserelin from the 21th day of previous cycle, daily 50 units and then it shall be decreased from the third day of cycle daily 20 units starting Gonal-F; continuing the process till formation of at least 2 follicles sized 17-18 cm and several follicles sized 14-16 cm; then injecting HCG.
Category
Treatment - Drugs
2
Description
Intervention group: from the 3rd day of cycle, Gonal-F is applied and from the 8th day injecting Cetrotide ampoule dosage 0.25 mg daily, till reaching the mentioned size of follicle in agonist group; then stopping stimuli and injecting HCG ampoule.