Protocol summary
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Study aim
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Determination of the effect of long term GnRH agonist before frozen embryo transfer in pregnancy outcomes in women with adenomyosis
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Design
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Clinical trial with control group
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Settings and conduct
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Avecinna infertility center
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: having at least 2 criteria in sonography; age between 20 to 40 years old; the candidate for frozen embryo transfer; the embryo has a quality A or blastocyst. exclusion criteria: recurrent miscarriage, azoospermia in male partner, using alternative infertility treatment services (such as donation), uncontrolled underlying diseases such as diabetes, hypertension, kidney dysfunction, lupus, and untreated thyroid dysfunction, abnormal karyotype, anatomical disorder of the uterus (such as Mullerian anomaly, submucosal myoma with compression effect), thrombophilia, candidate of using any immunosuppressive or immunomodulatory drugs and interventions such as endometrial scratch or Platelet-Rich Plasma.
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Intervention groups
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The intervention group will receive the GnRH agonist for 3 months.
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Main outcome variables
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Chemical and clinical pregnancy rate
General information
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Reason for update
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The trial end date was entered and the final volume of the sample was entered.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20160717028967N9
Registration date:
2019-01-01, 1397/10/11
Registration timing:
prospective
Last update:
2023-07-27, 1402/05/05
Update count:
2
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Registration date
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2019-01-01, 1397/10/11
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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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2019-03-01, 1397/12/10
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Expected recruitment end date
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2021-02-28, 1399/12/10
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Actual recruitment start date
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2019-03-01, 1397/12/10
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Actual recruitment end date
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2021-09-01, 1400/06/10
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Trial completion date
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2021-09-01, 1400/06/10
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Scientific title
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The effect of long term Gnrh agonist before frozen embryo transfer in pregnancy outcomes in women with adenomyosis in avecinna infertility center in 2 018_2019
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Public title
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The effect of long term GnRH agonist before frozen embryo transfer in pregnancy outcomes in women with adenomyosis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having at least 2 criteria in sonography
Age between 20 to 40 years old
The candidate for frozen embryo transfer
The embryo has a quality A or blastocyst
Exclusion criteria:
Recurrent abortion
Azospermia in sperm analysis of male partner
Uncontrolled medical condition
Abnormal karyotype
Uterine abnormal anatomy
Immune and coagulation dysfunction
Using immune suppressive medications
Using immune suppressive medications
Using another treatments for improvement of fertility success rate
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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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2
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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:
60
Actual sample size reached:
72
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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 equal groups (A and B) based on a randomized six-block table that is designed by Random allocation software.
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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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2018-11-20, 1397/08/29
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Ethics committee reference number
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IR.ACECR.AVICENNA.REC.1397.015
Health conditions studied
1
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Description of health condition studied
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People with Adenomyosis
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ICD-10 code
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N80
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ICD-10 code description
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Endometriosis
Primary outcomes
1
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Description
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Pregnancy rate
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Timepoint
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14 and 16 days after embryo transfer
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Method of measurement
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Beta test
2
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Description
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Clinical pregnancy rate
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Timepoint
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6th week of pregnancy
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Method of measurement
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With sonography
3
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Description
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Ongoing pregnancy rate
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Timepoint
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7th week of pregnancy
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Method of measurement
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With sonography
4
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Description
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Abortion rate before 12 weeks
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Timepoint
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12th week of pregnancy
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Method of measurement
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With sonography
Intervention groups
1
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Description
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Intervention group: The GnRH agonist group treated with a 11.25 mg intramuscular Triptorelin in the 3th menstural cycle day and after 12 weeks hormone replacement therapy starts with estradiol valerate. Then subjects will be followed with serial transvaginal ultrasound and after reaching to the endometrial thickness of 7 mm, progesterone will be added to the treatment and after 3 to 5 days embryo transfer will be performed.
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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 standard treatment begins with a 21 days of low dose contraceptives from the 3th day of the menstural cycle and a 1.875 mg intramuscular dose of Triptorelin in the 21th day of menstural cycle and the hormone replacement therapy starts with estradiol valerate in the next menstural cycle. Then subjects will be followed with serial transvaginal ultrasound and after reaching to the endometrial thickness of 7 mm, progesterone will be added to the treatment and after 3 to 5 days embryo transfer will be performed.
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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 for research, Avicenna infertility center
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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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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is 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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Yes - There is 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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Yes - There is 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
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Title and more details about the data/document
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I have no plans at this time
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When the data will become available and for how long
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I have no plans at this time
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To whom data/document is available
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I have no plans at this time
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Under which criteria data/document could be used
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I have no plans at this time
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From where data/document is obtainable
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I have no plans at this time
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What processes are involved for a request to access data/document
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I have no plans at this time
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Comments
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