Comparison of the the effect of Dual trigger by Gonadotropin releasing hormone and Human chorionic gonadotropin versus Human chorionic gonadotropin alone on pregnancy rates in infertile women with diminished ovarian reserve undergoing intracytoplasmic sperm injection-embryo transfer cycles
To assess the effect of Duel trigger with GnRH Agonist plus Human chorionic gonadotropin on pregnancy rates in infertile women with diminished ovarian reserve.
Design
Study design: Randomized, single blind, double center, controlled clinical trial with a parallel group design of 80 patients, enrolled between October 2018 to April 2019, phase 3.
Settings and conduct
Eighty infertile women with diminished ovarian reserve will be allocated to two groups of 40 based on random number table. Patients become aware and informed of intervention but physician doesn't any information .
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 20 to 45 years; normal hysterosalpingography; AMH levels < 1.5 ng/ml; antral follicular counts (AFC) < 7 in both ovaries; prior less than three failed in vitro fertilization cycles. Exclusion criteria: Normal ovarian response in ovulatory cycles or in vitro fertilization cycles.
Intervention groups
Intervention groups: Dual trigger with GnRH Agonist plus HCG on HCG injection on the day of IVF cycles. Control groups: Trigger with HCG alone on HCG injection on the day of IVF cycles.
Main outcome variables
Pregnancy rate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160815029374N4
Registration date:2019-05-09, 1398/02/19
Registration timing:retrospective
Last update:2019-05-09, 1398/02/19
Update count:1
Registration date
2019-05-09, 1398/02/19
Registrant information
Name
Marzieh Zamaniyan
Name of organization / entity
Mazandaran University of Medical Sciences, Sari, Iran.
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 5724
Email address
m.zamanian@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2019-04-20, 1398/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the the effect of Dual trigger by Gonadotropin releasing hormone and Human chorionic gonadotropin versus Human chorionic gonadotropin alone on pregnancy rates in infertile women with diminished ovarian reserve undergoing intracytoplasmic sperm injection-embryo transfer cycles
Public title
Effect of Agonist on reproduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Infertile women aged 20 to 45 years
Normal hysterosalpingography
AMH levels < 1.5 ng/ml
Antral follicular counts (AFC) < 7 in both ovaries
Prior less than three failed in vitro fertilization cycles
Exclusion criteria:
Normal ovarian response in ovulatory cycles or in vitro fertilization cycles
Age
From 20 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Care provider
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization, single blind, random number table
Blinding (investigator's opinion)
Single blinded
Blinding description
Randomization will be done by one ward nurse on Human chorionic gonadotropin day. Physician has not information about intervention, But patient know about it.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
No. 245, Mazandaran Universityof medical Sciences., Joibar Bolvar., Sari
City
Sari
Province
Mazandaran
Postal code
۴۳۴۷۵۷۲۴
Approval date
2019-02-20, 1397/12/01
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1398.006
Health conditions studied
1
Description of health condition studied
Diseases of the genitourinary system
ICD-10 code
N97; N98
ICD-10 code description
Female infertility; Complications associated with artificial fertilization
Primary outcomes
1
Description
Clinical pregnancy rate
Timepoint
Forth weeks after embryo transfer
Method of measurement
Utrasound
Secondary outcomes
1
Description
Oocyte recovery rate
Timepoint
48 hours after HCG injection
Method of measurement
Observation by microscopy
2
Description
Embryo rate
Timepoint
three days after oocyte recovery
Method of measurement
Observation by microscopy
3
Description
Miscarriage rate
Timepoint
Till twenty weeks after embryo transfer
Method of measurement
Ultrasound
4
Description
Oocyte quality
Timepoint
On oocyte recovery rate
Method of measurement
Observation by microscopy
Intervention groups
1
Description
Intervention group: Use of GnRH Agonist ampule (Variopeptil, 0.1 mg, SC, varian farmed, Iran) 0.2mg plus HCG (Choriomon ,5000 IU , IM, IBSA company , Switzerland) on HCG injection day.
Category
Treatment - Drugs
2
Description
Control group: Use of HCG injection alone (Choriomon ,5000 IU , IM, IBSA company , Switzerland) on HCG injection day.