Protocol summary
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Study aim
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Comparing the rate of pregnancy of Natural versus modified –natural cycle in frozen embryo transfer
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Design
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Single blinded randomized controlled clinical trial
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Settings and conduct
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Settings: Arash Women's Hospital
Blinding: Single-blind (outcome assessor and data analyst)
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: maximum age 38 years, regular menstrual cycles
Exclusion criteria: PCO, endometriosis, FSH ≥ 12 IVF and Severe Male Factor
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Intervention groups
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Group1: will receive vaginal progesterone after positive urinary LH kit. Group 2: 5000 IU HCG injection IM state, after presenting endometrial thickness>7 mm and 17 mm dominant folicule in transvaginal sonography.
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Main outcome variables
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Chemical pregnancy rate, clinical pregnancy rate, abortion rate, implantation rate, ongoing pregnancy rate
General information
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Reason for update
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Correcting Outcome Variables and blindness
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201607311556N92
Registration date:
2016-08-24, 1395/06/03
Registration timing:
registered_while_recruiting
Last update:
2021-12-01, 1400/09/10
Update count:
1
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Registration date
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2016-08-24, 1395/06/03
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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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Tehran University of Medical Sciences
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Expected recruitment start date
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2016-08-22, 1395/06/01
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Expected recruitment end date
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2018-02-20, 1396/12/01
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Actual recruitment start date
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2016-08-22, 1395/06/01
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Actual recruitment end date
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2018-04-20, 1397/01/31
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Trial completion date
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2018-08-22, 1397/05/31
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Scientific title
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Comparing the rate of pregnancy of Natural versus modified –natural cycle for endometrial preparation in frozen embryo transfer
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Public title
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Comparing the rate of pregnancy of Natural versus modified –natural cycle in frozen embryo transfer
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age below 38
Regular menstrual cycle
Normal BMI
The previous history of up to two IVF cycle
Exclusion criteria:
PCOD
History of endometriosis ( grade ≥3) according to AFS
Abnormal uterin
FSH ≥12
Sever male factor
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Age
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To 38 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
140
Actual sample size reached:
110
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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The patients underwent FET according to a computer-generated concealed randomization list using the block randomization method. There were six blocks. The statistician prepared random treatment assignments in sealed envelopes to conceal the randomization list from all research staff involved in enrollment and assessment.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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This study was designed as a single blinded study and the outcome investigators (infertility clinic’s midwife and the gynecologist who performed ultrasound assessments), and the statistician were unaware of the type of intervention until the end of the study.
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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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2016-08-09, 1395/05/19
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Ethics committee reference number
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IR.TUMS.MEDICINE.RBC.1395.426
Health conditions studied
1
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Description of health condition studied
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In vitro fertilization
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ICD-10 code
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Z31.2
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ICD-10 code description
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In vitro 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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6 weeks of pregnancy
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Method of measurement
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Ultrasonography
2
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Description
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Abortion rate
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Timepoint
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During 20 weeks of pregnancy
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Method of measurement
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Ulthrasonography, B-HCG
3
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Description
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Chemical Pregnancy Rate
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Timepoint
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2 weeks after embryo transfer
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Method of measurement
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Blood Pregnancy Test (BHCG)
Secondary outcomes
1
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Description
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Implantation
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Timepoint
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Gestational sac in 5 weeks of pregnancy
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Method of measurement
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ultrasonography
2
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Description
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Ongoing Pregnancy Rate
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Timepoint
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12 weeks of gestation
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Method of measurement
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The rate of pregnancies that continued ≥12 weeks of gestation.
3
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Description
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Endometrial thickness
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Timepoint
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At regular intervals until the endometrial thickness reaches above 7 mm
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Method of measurement
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Transvaginal Ultrasound
4
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Description
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No. of embryos transferred
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Timepoint
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At the time of embryo transfer
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Method of measurement
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Embryologist's report
Intervention groups
1
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Description
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The control group(1): progestron pessary administration after positive urinary LH kit
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Category
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Treatment - Drugs
2
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Description
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5000 Iu HCG injection IM state, after presenting endometrial thickness>7 mm and 17 mm dominant follicule in trans-vaginal ultrasonography
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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 scinces/Vice chancellor for research
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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