Protocol summary
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Study aim
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the aim of this study is to examine the effect of intrauterine administration of GCSF in IVF cycles on the fertility rate of infertile women suffering from moderate to severe endometriosis.
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Design
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The sample size of this study is 66 persons who will be randomly divided into two groups of GSF injection and without intervention. Participant are allocated by computerized list
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Settings and conduct
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This is a single-blind clinical trial study on 66 infertile women at Arash Hospital. After allocation, the first group receives GSF injection immediately after puncture and the second group has no intervention. Clinical pregnancy is assessed by transvaginal ultrasound 3 weeks after transfer.
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Participants/Inclusion and exclusion criteria
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The inclusion criteria: fertility due to endometriosis, age 18-40 years, moderate to severe endometriosis
Inclusion criteria: male factor infertility, evidence of a significant decrease in the ovarian reserve (FSH>11, AMH<0.5, decreased AFC), endocrine disorders (diabetes, thyroid diseases, hyperprolactinemia, hypothalamic amenorrhea, etc.), confirmed medical and immunologic diseases
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Intervention groups
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Intervention group: Immediately after ovarian puncture, 300µ GCSF is injected through a transcervical catheter into the uterine cavity Subjects in the control group received no intervention (blank control)
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Main outcome variables
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Clinical pregnancy
General information
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Reason for update
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Moderate and severe endometriosis were further explained.In this study, it was not possible to blind the patient
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20110731007165N7
Registration date:
2019-09-10, 1398/06/19
Registration timing:
retrospective
Last update:
2021-07-25, 1400/05/03
Update count:
1
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Registration date
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2019-09-10, 1398/06/19
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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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2019-01-15, 1397/10/25
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Expected recruitment end date
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2019-09-01, 1398/06/10
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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 administration of granulocyte-colony stimulating factor (GCSF) in IVF cycles on the fertility rate of infertile women suffering from moderate to severe endometriosis
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Public title
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Effect of intrauterine administration of granulocyte-colony stimulating factor (GCSF) in IVF cycles on the fertility rate of infertile women
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
First time IVF due to infertility
Moderate to severe endometriosis (according to laparoscopic criteria, moderate endometriosis was defined as Adhesion affecting Fallopian tubes or ovaries, and severe endometriosis was defined as the involvement of Fallopian tubes, ovaries, and cul-de-sac)
Age 18-40 years
Fertility due to endometriosis
Moderate -to –severe endometriosis was characterized by endometrial glands and stroma at least 5 mm beneath the peritoneum or an ovarian endometriotic cyst (endometrioma)
Exclusion criteria:
Male factor infertility.
Evidence of a significant decrease in the ovarian reserve (FSH>11, AMH<0.5, decreased AFC),
Endocrine disorders (diabetes, thyroid diseases, hyperprolactinemia, hypothalamic amenorrhea, etc.)
, confirmed medical and immunologic diseases (SLE, rheumatoid arthritis, antiphospholipid syndrome, cardiovascular, liver, and renal diseases),
and congenital uterine anomalies and uterine cavity disorder (bicornuate uterus, unicornuate uterus, Asherman syndrome, myoma, polyps, etc.).
Donation candidates (ovum donation and surrogate utrus) were also excluded from the study
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Age
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From 18 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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No information
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Sample size
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Target sample size:
66
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Our sample size is 66 people, with 33 people in each group.patients were allocated by simple randomization.In this method RANDBETWEEN function in the Excel program is used to generate a random number between 1 and 2.
This is repeated 66 times.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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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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2019-01-12, 1397/10/22
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1397.787
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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N97.8
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ICD-10 code description
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Female infertility of other origin
Primary outcomes
1
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Description
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clinical pregnancy
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Timepoint
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3 weeks after embryo transfer
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Method of measurement
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Vaginal ultrasound
Intervention groups
1
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Description
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Intervention: Immediately after ovarian puncture, 300µ GCSF is injected into the uterine cavity
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Category
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Treatment - Drugs
2
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Description
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Control group: no intervention
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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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Tehran 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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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