Comparison the effect of Gonadotropin releasing hormone agonist administration versus vaginal Progesterone on serum progesterone in luteal phase in ovarian hyperstimulation and intrauterine insemination cycles in unexplained infertility
This study is a prospective randomize controlled trial study. In this study we will compare the effect of Gonadotropin releasing hormone agonist administration versus vaginal Progesterone on serum progesterone in luteal phase in ovarian hyperstimulation and intrauterine insemination cycles in unexplained infertility. 242 patients (unexplained infertility reffered to the infertility Center of Mirza khochak khan Hospital) according to inclusion criteria (age<40 years old; FSH<10; normal Serum prolactin and thyroid function test; duration of infertility at least 1 year for each case; Normal hysterosalpigography in 6 month ago; normal semen analysis with WHO criteria (20 million sperm inml, 50%motility, 30% normal morphology); Regular menstruation cycles with midluteal progesterone>10ng/ml in previous cycles) and exclusion criteria (previous ovarian surgery; Single ovary; polycystic ovaries on ultrasound examination; hypogonadotropic hypogonadism) will be selected.
In all patients, transvaginal ultrasonography will be performed on 3rd day of the menstrual cycle and then will be stimulated with dose of 100mg Clomiphene from 3rd day to 7th day menstrual cycles.Then administration of Gonadotropin (75IU IM)will begin from 7th and 8th day cycle .Ovarian response will be assesed with trans vaginal sonography from 10th day of each cycle. Cycles will trigger with 10000 IU HCG when at least one dominant follicle has reach 18 mm in diameter.The intrauteine insemination will be performed 36 hrs after HCG administration with a intra uteine insemination disposable catheter.Then all cycles will be divided in 2 group. In first group, luteal phase will be supported with vaginal progesterone 400mg daily ,1 days after insemination until 14 days.The second group will receive a single subcutaneous injection of 0.1 mg GNRH Agonist( triptoreline) 4 days after intra uteine insemination. Serum progesterone will be measured 10 days after intra uteine insemination .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205159762N1
Registration date:2012-07-11, 1391/04/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-07-11, 1391/04/21
Registrant information
Name
Jaleh Mohamadpoor
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4422 3291
Email address
j-mohamadpoorm@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for research of Tehran University of Medical Sciences
Expected recruitment start date
2012-06-09, 1391/03/20
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of Gonadotropin releasing hormone agonist administration versus vaginal Progesterone on serum progesterone in luteal phase in ovarian hyperstimulation and intrauterine insemination cycles in unexplained infertility
Public title
Comparison the effect of Gonadotropin releasing hormone agonist administration versus vaginal Progesterone on serum progesterone in luteal phase in ovarian hyperstimulation and intrauterine insemination cycles in unexplained infertility
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age<40 years old; FSH<10; normal Serum prolactin and thyroid function test; duration of infertility at least 1 year for each case; Normal hysterosalpigography in 6 month ago; normal semen analysis with WHO criteria (20 million sperm inml, 50%motility, 30% normal morphology); Regular menstruation cycles with midluteal progesterone>10ng/ml in previous cycles
exclusion criteria: previous ovarian surgery; Single ovary; polycystic ovaries on ultrasound examination; hypogonadotropic hypogonadism
Age
From 17 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
242
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 o fVice-Chancellor for research of Tehran University of Medical Sciences
Street address
Vice-Chancellor for research of Tehran University of Medical Sciences,Ghods Avenve, Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
Approval date
2012-06-09, 1391/03/20
Ethics committee reference number
91-02-39-18352
Health conditions studied
1
Description of health condition studied
infertility
ICD-10 code
n97.9
ICD-10 code description
female infertility,unspecified
Primary outcomes
1
Description
serum progesterone in luteal phase
Timepoint
10 days after intra uterine insemination
Method of measurement
blood sampling-ng/ml
Secondary outcomes
1
Description
pregnancy
Timepoint
14 days after intra uterine insemination
Method of measurement
blood sampling-iu/ml
Intervention groups
1
Description
Group1:Clomiphene 100mg daily from 3rd day to 7th day of the menstrual cycle,Gonadotopin(75 IU IM) injection 7th and 8th day , Human chorionic gonadotropin (10000 IU IM) will be administered when dominant follicle18 mm will measure,The intra uterine isemination will be performed 36 hrs after HCG administration, Vaginl progesterone (400 mg/day) begin from a day after intrauterine insemination to 14 days
Category
Treatment - Drugs
2
Description
Group2: Clomiphene 100mg daily from 3rd day to 7th day of the menstrual cycle,Gonadotopin(75 IU IM) injection 7th and 8th day , Human chorionic gonadotropin (10000 IU IM) will be administered when dominant follicle18 mm will measure,The intra uterine isemination will be performed 36 hrs after HCG administration,Triptoreline (0.1 mg Sc) injection 4 days after intrauterine insemination
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ivf Center Mirzakochakkhan Hospital
Full name of responsible person
Jaleh Mohamadpoor
Street address
Ivf Center Mirzakochakkhan Hospital,North Ostad nejatolahi, Karimkhan street, Tehran,Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for research of Tehran University of Medical Sciences
Full name of responsible person
Miss Rahmani
Street address
Vice-chancellor for research of Tehran University of Medical Sciences ,Ghods Avenve,Keshavarz Blvd,Tehran,Iran
City
Tehran
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 of Tehran University of Medical Sciences