Protocol summary
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Study aim
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Comparison of two endometrial preparation protocols for frozen-thawed embryo transfer in patient with adenomyosis
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Design
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This study is designed as a randomized, single-blind clinical trial with parallel groups with a sample size of 65 individuals per group
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Settings and conduct
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This study will be done on 130 women with adenomyosis undergoing frozen embryo transfer. After random allocation, they will be treated withGnRH+HRT or HRT. Pregnancy outcomes will be assessed in both groups
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Age 30-45 Years First or second cycle of embryo transfer, Normal uterine cavity adenomyosis with or without endometriosis and myoma. Exclusion criteria: recurrent implantation failure, hydrosalpinx, uterine anomaly , sever male factor infertility myoma >5 cm sever endometriosis uterine distortion because of myoma
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Intervention groups
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Intervention group1: endometrial preparation with HRT+GnRHa
Intervention group2: endometrial preparation with HRT
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Main outcome variables
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chemical pregnancy and clinical pregnancy and ongoing pregnancy.
General information
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Reason for update
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Due to the fact that the rate of chemical pregnancy, the rate of miscarriage, and the rate of twins pregnancy have also been investigated and followed up, therefore, they were added in the primary and secondary results section.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20090526001952N13
Registration date:
2020-12-24, 1399/10/04
Registration timing:
registered_while_recruiting
Last update:
2023-01-03, 1401/10/13
Update count:
4
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Registration date
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2020-12-24, 1399/10/04
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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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2020-05-09, 1399/02/20
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Expected recruitment end date
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2021-03-10, 1399/12/20
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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 the pregnancy outcomes in patients with adenomyosis after pitutary down-regulation with GnRHagonist plus hormone replacement therapy versus HRT for endometrial preparation in frozen embryo transfer cycles
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Public title
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Comparison of two endometrial preparation protocols for frozen-thawed embryo transfer in patient 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:
Age 30-45 Years
First or second cycle of embryo transfer
Presence of adenomyosis, either focal or generalized, with or without concomitant diagnosis of endometriosis and myoma
Normal uterine cavity
Exclusion criteria:
recurrent implantation failure,
hydrosalpinx,
uterine anomaly ,
sever male factor infertility
myoma >5 cm
sever endometriosis
uterine distortion because of myoma
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Age
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From 30 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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- Participant
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
140
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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 140 people, with 70 people in each group. The Block randomization method was designed by the epidemiologist using STATA version . 13 software. The kind of treatment will put in the pocket. When the doctor confirmed the eligibility of the patient the midwife will give the pocket to the doctor.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Because of the kind of intervention, The patient will be aware of the treatment. Outcomes assessor will not be informed about the kind of treatment A statistician who is unaware of the type of interventions in each group will analyze the data
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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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2020-04-30, 1399/02/11
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Ethics committee reference number
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IR.TUMS.MEDICINE.REC.1399.034
Health conditions studied
1
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Description of health condition studied
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Infertility in adenomyosis
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ICD-10 code
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N97.2
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ICD-10 code description
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Female infertility of uterine origin
Primary outcomes
1
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Description
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Clinical pregnancy rate
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Timepoint
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Observation of at least one fetus with cardiac activity at 4-6 weeks after embryo transfer in vaginal ultrasound
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Method of measurement
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Vaginal ultrasound
2
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Description
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Chemical pregnancy rate
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Timepoint
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14 days after embryos transfer
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Method of measurement
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by using laboratory kits for blood Beta-hCG assay
Secondary outcomes
1
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Description
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Live birth rate
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Timepoint
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The delivery of a fetus who shows evidence of life after that is entirely outside of the mother
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Method of measurement
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Delivery report from hospital
2
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Description
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Miscarriage rate
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Timepoint
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Before the 20th week of pregnancy
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Method of measurement
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Ultrasound evidence of clinical pregnancy loss before 20 weeks of gestation
3
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Description
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Twin pregnancy rate
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Timepoint
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6 to 7 weeks after embryo transfer
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Method of measurement
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observation of two gestational sacs along with the fetal poles with heart beat in ultrasound examination
Intervention groups
1
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Description
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Control group: This group will received dipherelin (3.75 mg) On day 3 after LMP,and then repeat after28 days .7-14 days after second dose then estradiol valerate is administered at the dose of 2 mg and will be increased to 6 mg /daily. The patient will be examined after 10-14 days. An endometrial thickness of 8 mm or more is optimum for progesterone administration ,(an injectable progestron 100 mg /daily) otherwise the dose of estradiol will be increased up to 8 mg. If the optimal endometrial thickness is not achieved after 20 days, embryo transfer will be canceled.
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Category
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Treatment - Drugs
2
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Description
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Intervention group: This group will be received estradiol valerate (Aboureihan Co.). On day2 after LMP, estradiol valerate is administered at the dose of 2 mg and will be increased up to 6 mg. The patient will be examined after 10-14 days. An endometrial thickness of 8 mm or more is optimum for progesterone administration (ingectable progestron 100 mg/daily), otherwise the dose of estradiol will be increased up to 8 mg. If the optimal endometrial thickness is not achieved after 20 days, embryo transfer will be canceled.
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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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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