One of the important problems in women treated for IVF cycle is increasing of mature oocytes. Inclusion criteria: male and tubal infertility and FSH<10(IU/L). Exclusion criteria: the cause of infertility other than male and tubal factor. The study is a randomized clinical trial by the manufacturer to include a 180 women referring from Yazd research and clinical center for infertility from 2009 till 2011 .participants are assessed for eligibility according to defined criteria. Patients undergo pituitary desensitization with superfact (sc) at a dose of 0.4 µg/day starting in the mid luteal phase and after menstruation continued at a dose of 0.2 µg/day until 24 hours before the administration of r-hcG or U-HCG. Treatment with menogon is started at the second day of menstruation .The ovarian response is monitored by vaginal sonography and the dose is adjusted accordingly triggering of final follicular maturation with r- HCG (interventional group) or U- HCG (control group) is performed in the evening. Oocyte is retrieved by follicular aspiration 34-36 hrs after r-hcG or U-hcG. Up to three embryos are replaced in the uterine cavity on day 3after ovum pick up. Luteal phase support is designed by progesterone (400mg micronized progesterone vaginally two times a day). After 14 days of embryo transfer βHCG is checked and clinical pregnancy is documented by vaginal sonography at 6 weeks of gestational age.
General information
Acronym
IVF
IRCT registration information
IRCT registration number:IRCT201107034339N2
Registration date:2011-08-09, 1390/05/18
Registration timing:retrospective
Last update:
Update count:2
Registration date
2011-08-09, 1390/05/18
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
Yazd research and clinical center for infertility
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2011-03-21, 1390/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison the effect of Recombinant HCG and urinary HCG in infertile women at IVF cycle
Public title
comparison the effect of two kind of HCG in IVF cycle
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : male infertility;tubal factor;aged between 18-35 years;FSH<10(IU/L). Exclusion criteria : previous ovarian surgery; FSH >10(IU/L);the cause of infertility other than male and tubal factor.
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
180
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
Boali Street, Safaieh, Yazd, Research and clinical center
City
Yazd
Postal code
8916877391
Approval date
2009-02-01, 1387/11/13
Ethics committee reference number
2692
Health conditions studied
1
Description of health condition studied
female infertility
ICD-10 code
N97
ICD-10 code description
ناباروری زنان
Primary outcomes
1
Description
number and maturity of oocyte
Timepoint
ovum pick up
Method of measurement
by microscope
Secondary outcomes
1
Description
chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
blood
Intervention groups
1
Description
Patients undergo pituitary desensitization with superfact (sc) at a dose of 0.4 µg/day starting in the midluteal phase and after menstruation continued at a dose of 0.2 µg/day until 24 hours before the administration of r-hcG or U-hcG. Treatment with menogon is started at the second day of menstruation .The ovarian response is monitored by vaginal sonography and the dose is adjusted accordingly triggering of final follicular maturation with U-hcG (control group) is performed in the evening. Oocyte was retrieved by follicular aspiration 34-36 hrs after r-hcG or U-hcG. Up to three embryos are replaced in the uterine cavity on day 3after ovum pick up. Luteal phase support is designed by progesterone (400mg micronized progesterone vaginally two times a day). After 14 days of embryo transfer βHCG is checked and clinical pregnancy is documented by vaginal sonography at 6 weeks of gestational age
Category
Treatment - Drugs
2
Description
Patients undergo pituitary desensitization with superfact (sc) at a dose of 0.4 µg/day starting in the midluteal phase and after menstruation continued at a dose of 0.2 µg/day until 24 hours before the administration of r-hcG or U-hcG. Treatment with menogon is started at the second day of menstruation .The ovarian response is monitored by vaginal sonography and the dose is adjusted accordingly triggering of final follicular maturation with r-hcG (interventional group) is performed in the evening. Oocyte is retrieved by follicular aspiration 34-36 hrs after r-hcG or U-hcG. Up to three embryos are replaced in the uterine cavity on day 3after ovum pick up. Luteal phase support is designed by progesterone (400mg micronized progesterone vaginally two times a day). After 14 days of embryo transfer βHCG is checked and clinical pregnancy is documented by vaginal sonography at 6 weeks of gestational age
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. Maryam Eftekhar
Street address
Boali street, Safaieh, Yazd, Research and clinical center for infertility
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Dr. Maryam Eftekhar
Street address
Boali Street, Safaieh, Yazd, Research and clinical center
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.Elham Rahmani
Position
Obestetrics and Gynecologist
Other areas of specialty/work
Street address
Boali Street, Safaieh, Yazd, Research and clinical center
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
rahmani@bpums.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
Dr Maryam Eftekhar
Position
obestetrics and gynecologist-fellowship of infertility
Other areas of specialty/work
Street address
Boali Street, Safaieh, Yazd, Research and clinical center
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
+98 35 1824 7087
Email
eftekharmaryam@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)