Protocol summary
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Study aim
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To assess the effect of Duel trigger with GnRH Agonist plus Human chorionic gonadotropin on pregnancy rates in infertile women with diminished ovarian reserve.
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Design
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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.
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Settings and conduct
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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 .
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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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.
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Main outcome variables
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Pregnancy rate
General information
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Reason for update
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The wrong date was selected by mistake and needs to be corrected.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160815029374N4
Registration date:
2019-05-09, 1398/02/19
Registration timing:
prospective
Last update:
2025-07-21, 1404/04/30
Update count:
1
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Registration date
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2019-05-09, 1398/02/19
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-05-15, 1398/02/25
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Expected recruitment end date
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2019-11-16, 1398/08/25
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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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
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Public title
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Effect of Agonist on reproduction
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 20 years old to 45 years old
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Gender
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Female
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Phase
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3
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Groups that have been masked
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple individual randomization, single blind, random number table
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Randomization will be done by one ward nurse on Human chorionic gonadotropin day. Physician has not information about intervention, But patient know about it.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-02-20, 1397/12/01
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Ethics committee reference number
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IR.MAZUMS.IMAMHOSPITAL.REC.1398.006
Health conditions studied
1
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Description of health condition studied
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Diseases of the genitourinary system
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ICD-10 code
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N97; N98
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ICD-10 code description
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Female infertility; Complications associated with artificial fertilization
Primary outcomes
1
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Description
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Clinical pregnancy rate
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Timepoint
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Forth weeks after embryo transfer
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Method of measurement
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Utrasound
Secondary outcomes
1
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Description
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Oocyte recovery rate
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Timepoint
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48 hours after HCG injection
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Method of measurement
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Observation by microscopy
2
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Description
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Embryo rate
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Timepoint
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three days after oocyte recovery
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Method of measurement
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Observation by microscopy
3
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Description
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Miscarriage rate
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Timepoint
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Till twenty weeks after embryo transfer
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Method of measurement
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Ultrasound
4
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Description
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Oocyte quality
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Timepoint
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On oocyte recovery rate
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Method of measurement
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Observation by microscopy
Intervention groups
1
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Description
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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.
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Category
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Treatment - Drugs
2
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Description
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Control group: Use of HCG injection alone (Choriomon ,5000 IU , IM, IBSA company , Switzerland) on HCG injection day.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Vice chancellor of Mazandaran University of Medical Science.
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available