According to benefit of antagonist protocol in IVF cycle, the aim of this study is some changes in antagonist protocol as increasing pregnancy rate. Inclusion criteria is the patient with male and tubal factor infertility and exclusion criteria is FSH >10. A total 60 patients undergoing this study at Yazd research and clinical center for infertility from March 2011 to March 2012 were included. All patients received routine flexible GNRH antagonist when the leading follicle diameter reached ≥ 13 mm and HMG/rFSH is starting on cycle day 2 until appropriate dominant follicles are reached. Only 30 patients randomly received GNRH antagonist on day 1, 2 and 3 of menstrual cycle as interventional group. Serial ultrasonography is done for evaluation of follicular size and endometrial thickness as needed. UHCG 10000 IU is administered to induce ovulation when dominant follicle is ≥18mm .Then oocyte retrieval is done 34-36 hours after HCG administration. The number of oocyte retrieval and pregnancy rate are compared in both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108044339N5
Registration date:2011-08-24, 1390/06/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-08-24, 1390/06/02
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
2011-03-21, 1390/01/01
Expected recruitment end date
2012-03-20, 1391/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the efficacy of early and short follicular GnRH antagonist in IVF cycles
Public title
A new protocol in IVF
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: FSH<10, 20<age<39, male or tubal infertility. Exclusion criteria:IVF failure, FSH>10, 20>age >39, endometriosis,infertility due to other than male or tubal factor, the patient with liver and kidney and heart disease.
Age
From 20 years old to 39 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Postal code
8916877391
Approval date
2011-08-08, 1390/05/17
Ethics committee reference number
1476
Health conditions studied
1
Description of health condition studied
female infertility
ICD-10 code
N97
ICD-10 code description
female infertility
Primary outcomes
1
Description
the number of oocyte retrival
Timepoint
the day of puncture
Method of measurement
counting by microscope
Secondary outcomes
1
Description
chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
serum BHCG
Intervention groups
1
Description
As control group, 30 patients randomly received routine flexible GNRH antagonist when the leading follicle diameter reached ≥ 13 mm and HMG/rFSH is starting on cycle day 2 until appropriate dominant follicles are reached. Serial ultrasonography is done for evaluation of follicular size and endometrial thickness as needed. UHCG is administered to induce ovulation when dominant follicle is ≥18mm .Then oocyte retrieval is done 34-36 hours after HCG 10000 IU administration. The number of oocyte retrieval and pregnancy rate are compared in both groups.
Category
Treatment - Drugs
2
Description
30 patients randomly received routine flexible GNRH antagonist when the leading follicle diameter reached ≥ 13 mm and HMG/rFSH is starting on cycle day 2 until appropriate dominant follicles are reached. In addition these patients as interventional group received GNRH antagonist on day 1, 2 and 3 of menstrual cycle, too. Serial ultrasonography is done for evaluation of follicular size and endometrial thickness as needed. UHCG 10000 IU is administered to induce ovulation when dominant follicle is ≥18mm .Then oocyte retrieval is done 34-36 hours after HCG administration. The number of oocyte retrieval and pregnancy rate are compared in both groups.
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 Robab Davar
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd research and clinical center for infertility
Full name of responsible person
Dr. Robab Davar
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
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,Student of fellowship
Other areas of specialty/work
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
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 Robab Davar
Position
Obestetrics and Gynecologist, fellowship of infertility
Other areas of specialty/work
Street address
Yazd research and clinical center for infertility, Booali Street, Safaieh, Yazd
City
Yazd
Postal code
8916877391
Phone
+98 35 1824 7085
Fax
Email
r_davar@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)