Effect of gonadotropin-releasing hormone analogue (GnRh-a ) for triggering and luteal phase support in antagonist –in vitro fertillization cycles (IVF) in normal responders and comprission with standard protocol
Effect of Gonadotropin realeasing hormon aganoist( GnRH-a )for triggering and luteal phase support in IVF cycles
Design
This double blinded randomized clinical trial study is done in 72 antagonist IVF cycles in women aged 20-40 years in Taleghani hospital. After taking consent form patients will arrange in stydy or control group
Settings and conduct
This study is done in 72 antagonist based cycles performed in women aged 20-40 years in in vitro fertilization(IVF) unit of Taleghani hospital. Stimulation will be done on 3th menstrual cycle.
Final oocyte maturation in GnRH-a groups will trigger with single double bolus triptorelline (0.1 mg each ) . Double bolus UHCG (5000 IU each) will be prescribed in control group. Subsequently, luteal support will be done with subcutaneousely triptorelline (GnRH-a group) or intramuscular progestrone100mg/day ( P supplementation group).
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age : 20-40 years
BMI: 20-30
Fresh embryo transfer cycles
serum FSH of third menstrual day below 10 and absence of low ovarian response
Exclusion criteria:Failed fertilization
Sever endometriosis
Decreased ovarian reserve
Absence of good quality embryo
Ovarian stimulation hyper stimulation (more than 18 mature follicles during ovarian stimulation )
Intervention groups
Subcutaneous injection of triptorelline .2 mg and continue .2mg/BD for luteal phase support
Effect of gonadotropin-releasing hormone analogue (GnRh-a ) for triggering and luteal phase support in antagonist –in vitro fertillization cycles (IVF) in normal responders and comprission with standard protocol
Public title
Effect of Gonadotropin-releasing hormone analogue( GnRh-a ) for in vitro fertillization cycles (IVF)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women aged 20-40 years normal respondering in IVF cycles
Body mass index between 20-30
Fresh embryo transfer cycles
Serum FSH of third menstrual day below 10 and absence of low ovarian response according bologna criteria
Exclusion criteria:
Failed fertilization
Sever endometriosis
Decreased ovarian reserve.
Unwillingness to continue
Absence of good quality embryo
Ovarian stimulation hyper stimulation (more than 18 mature follicles during ovarian stimulation )
Age
From 20 years old to 40 years old
Gender
Female
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Subjects were assigned into two groups, using permuted block randomization method with size of block of two. Package block rand in R statistical software was used for preparing randomization list.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is double-blind study, that the participants do not know which of the two control or test groups belong, and also the observers (researchers) do not know who the group is.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak, Yaman St, Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2018-09-30, 1397/07/08
Ethics committee reference number
IR.SBMU.REC.1397.029
Health conditions studied
1
Description of health condition studied
Noninflammatory disorders of female genitalia tract
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
Clinical pregnancy
Timepoint
4 weeks after embryo transfer
Method of measurement
Transvaginal Ultrasound
2
Description
Chemical pregnancy
Timepoint
2 weeks after embryo transfer
Method of measurement
serum βHcG test
3
Description
OOcyte number
Timepoint
After ovarian puncture
Method of measurement
Evaluation with reproductive biologist after ovarian puncture
Secondary outcomes
1
Description
Ongoing pregnancy
Timepoint
10 weeks after embryo transfer
Method of measurement
Fetal heart beat in ultrasound
2
Description
Abortion rate
Timepoint
Loss of pregnancy before 20 weeks
Method of measurement
Ultrasonography
Intervention groups
1
Description
Intervention group: Subcutaneous injection of Triptorelin(0/2 mg each of them 0/1 mg variopeptyl company ) for trigger of follicle only single dose( on triggering day)
Category
Treatment - Drugs
2
Description
Second intervention group:Continue injection of Triptorelin 0/2mg/BD (each of them 0/1 mg variopepty company ) until 2 weeks after embryo transfer
Category
Treatment - Drugs
3
Description
Control group:Intramuscular bolus injection of UHCG 10000 IU (Pregnyl ® 5000 I.U. powder for solution for injection)for trigger of follicle only single dose( on triggering day)
Category
Treatment - Drugs
4
Description
Second control group: Continue injection of progestrone two ampula daily( Iran hormon - each of ampula 50 mg) until 2 weeks after embryo transfer
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
IVF infertility & IVF ward of Talghani Hospital
Full name of responsible person
Hashemi Teibeh
Street address
Shahid Beheshti University of medical science
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 2558
Email
Hashemit89@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences, Yaman st., Velenjak, Chamran highway
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 2558
Email
nazari@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?