Protocol summary
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Study aim
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Effect of human chorionic gonadotropin and hyaluronan acid culture medium (embryo glue) in infertile women.
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Design
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A controlled, single blind, randomized phase 2 clinical trial on 158 patients.
Randomization: Patients are divided into intervention and control groups randomly by using the block randomization method, and just the analyst will be blinded.
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Settings and conduct
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In Infertility Treatment Center of Imam Khomeini Hospital in Sari, for all eligible patients, endometrial preparation was performed according to the treatment protocol, and procedure of intervention will be explained to all patients.
Then patients were randomly divided into two intervention and control groups using the block randomization method and after the intervention and follow-up of the outcomes, the data will be sent to the analyst as the results of two groups (A and B), and thus the analyst will be blinded.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Infertile women in frozen-thawed embryo transfer cycle and with grade A and B embryos;
Exclusion criteria: Presence of uterine abnormalities, uncontrolled endocrine disease
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Intervention groups
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Intervention group: the group for which intrauterine infusion of HCG and embryo glue will be used. In this group, 20 minutes before embryo transfer, 500 units of HCG and 15 microliters of embryo culture medium (stage one stop origin) by catheter embryo transfer is loaded into the uterus guided by abdominal ultrasound. after 20 minutes the embryos are transferred into the embryo transfer catheter and are transferred into the uterus guided by abdominal ultrasound.
Control group: The group for which routine infertility treatment protocols will be used.
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Main outcome variables
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Implantation, abortion, chemical, clinical and ongoing pregnancy,
General information
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Reason for update
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The sample size was increased to 158 people in order to increase the value of the study and refer to it.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20221126056614N1
Registration date:
2023-02-22, 1401/12/03
Registration timing:
registered_while_recruiting
Last update:
2024-07-30, 1403/05/09
Update count:
1
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Registration date
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2023-02-22, 1401/12/03
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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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2022-12-06, 1401/09/15
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Expected recruitment end date
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2024-04-20, 1403/02/01
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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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Effect of intrauterine infusion of human chorionic gonadotropin and cultural environment of hyaluronan acid (embryo glue) on pregnancy outcomes in women with recurrent implantation failure
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Public title
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Effect of human chorionic gonadotropin and embryo glue in infertility
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Women who have a history of at least 3 failed transfer cycles or failed transfer of 4 good quality (grade A or B) embryos.
Women who are in the frozen-thawed embryo transfer cycle and their preparation is done using estrogen and progesterone.
Women who have at least one grade A or B embryo on the day of embryo transfer
Exclusion criteria:
Donated oocyte
Donated embryo
Surrogacy
Presence of hydrosalpinx in hysterosalpingography or ultrasound
History of uncontrolled endocrine diseases: diabetes, hypothyroidism and hyperthyroidism
Male factor infertility (azoospermia)
Difficult embryo transfer (needs manipulation of the cervix or under anesthesia)
Uterine abnormalities
Presence of severe endometriosis and endometrioma
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Age
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From 20 years old to 40 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:
158
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Patients are divided into two groups with equal size using the random block method of 4 people, which is done by the Randomize Allocate software and using their admission row number.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Regarding the method of blinding, after conducting the intervention and following up the outcomes, the data will be sent to the analyst in the form of results in two groups (A and B), in this way, the analyst does not know which patients are in the intervention group and which patients are in the control group, and the study will be single blind.
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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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2022-10-18, 1401/07/26
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Ethics committee reference number
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IR.MAZUMS.IMAMHOSPITAL.REC.1401.038
Health conditions studied
1
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Description of health condition studied
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Infertility
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ICD-10 code
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N98
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ICD-10 code description
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Complications associated with artificial fertilization
Primary outcomes
1
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Description
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Rate of Implantation
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Timepoint
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5 weeks after intervention
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Method of measurement
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Ultrasound
2
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Description
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Rate of Abortion
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Timepoint
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18 weeks after intervention
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Method of measurement
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Fetus excretion
3
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Description
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Rate of chemical pregnancy
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Timepoint
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3-4 weeks after intervention
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Method of measurement
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Pregnancy test
4
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Description
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Rate of clinical pregnancy
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Timepoint
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5 weeks after intervention
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Method of measurement
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Ultrasound
5
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Description
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Ongoing pregnancy
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Timepoint
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38 weeks after intervention
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Method of measurement
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Delivery
Intervention groups
1
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Description
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Intervention group: intrauterine infusion of human chorionic gonadotropin and embryo glue. In this group, 20 minutes before embryo transfer, 500 units of HCG (Pharmed Daru) and 15 microliters of embryo culture medium (stage one stop origin) were loaded into the uterus by the embryo transfer catheter guided by abdominal ultrasound. after 20 minutes, the embryos are transferred into the embryo transfer catheter and are transferred into the uterus under the guidance of abdominal ultrasound.
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Category
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Treatment - Drugs
2
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Description
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Control group: In the control group, the embryos are transferred into the culture medium without the use of HCG and hyaluronic acid and then transferred into the uterine cavity.
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Category
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N/A
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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Mazandaran University of Medical Sciences
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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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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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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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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The protocol and method of conducting the study can be provided to researchers for use in other studies.
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When the data will become available and for how long
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The access period starts 2 months after the results are published
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To whom data/document is available
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Researchers working in academic and scientific institutions and people working in industry
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Under which criteria data/document could be used
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For use in other studies
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From where data/document is obtainable
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Postal address: Imam Khomeini Hospital, Amir Mazandarani Ave, Sari.
Email address: Pegahjafarifard.m.d@icloud.com
Phone number: 0098 9127372572
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What processes are involved for a request to access data/document
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With sending Email and in one week
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Comments
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