Protocol summary
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Study aim
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Evaluation and comparison of clinical pregnancy rate in two methods of endometrial preparation using hormone administration method and natural modified method in frozen embryo transfer cycle.
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Design
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The current study is clinical and prospective. Patients are randomly assigned to two endometrial preparation groups. Basic ultrasound is performed for 128 patients on day 2 of the cycle and they are planned to be placed in each of the endometrial preparation protocols.
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Settings and conduct
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This study is conducted in Imam Khomeini Hospital in Sari
Patients in the modified normal cycle group undergo an ultrasound scan on day 10 to 12 of the menstrual cycle to determine the size of the dominant follicle. And when a follicle equal to or greater than 18 mm is seen, ovulation is induced by Ovitrelle injection, and progesterone begins three days later of Ovitrelle injection . will be For patients in the hormone administration cycle group treated with estradiol valerate, ultrasound is performed starting from the 2nd day of menstruation and approximately 10 days after the start of estradiol treatment, when the thickness of the endometrium reaches 8 mm, progesterone will start.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria :
Age 20-40 years with monthly menstrual cycles; Normal BMI (18-30 kg/m2)
; At the time of embryo transfer, at least one or two good-quality embryos;
Patients with first or second transfusion
Exit criteria:
Women with uterine anatomic abnormalities, hydrosalpinx, endometriosis.
ovulation disorders.
needed preimplantation genetic testing.
recurrent miscarriages and recurrent implantation failure.
medical conditions who were interdicted ART/pregnancy
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Intervention groups
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Two groups of frozen embryo transfer with endometrium preparation protocol with hormone administration method and natural modified method
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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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The study's sampling and completion were completed later than the announced time, and the realized volume was greater than the determined sample size. In addition, more outcomes were examined.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20240302061147N1
Registration date:
2024-05-27, 1403/03/07
Registration timing:
registered_while_recruiting
Last update:
2025-05-05, 1404/02/15
Update count:
3
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Registration date
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2024-05-27, 1403/03/07
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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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2024-04-20, 1403/02/01
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Expected recruitment end date
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2024-07-22, 1403/05/01
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Actual recruitment start date
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2024-04-29, 1403/02/10
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Actual recruitment end date
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2024-08-07, 1403/05/17
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Trial completion date
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2024-10-21, 1403/07/30
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Scientific title
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Evaluation and comparison of clinical pregnancy rate in two methods of endometrial preparation using hormone therapy method and modified natural cycle of in frozen embryo transfer cycle.
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Public title
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Evaluation and comparison of clinical pregnancy rate in two methods of endometrial preparation using hormone therapy method and modified natural cycle of in frozen embryo transfer cycle.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age 20-40 years with monthly menstrual cycles of 21 to 35 days
Normal BMI (18-30 kg/m2)
At the time of embryo transfer, there should be at least one or two embryos with good-quality
Patients with first or second transfer
Exclusion criteria:
Women who were diagnosed with uterine anatomic abnormalities, either inborn or acquired, hydrosalpinx, and endometriosis.
The patients with ovulation disorders.
Women who needed preimplantation genetic testing.
Women who suffered from recurrent miscarriages and recurrent implantation failure.
Women with medical conditions who were interdicted ART/pregnancy.
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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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N/A
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Groups that have been masked
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- Investigator
- Data analyser
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Sample size
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Target sample size:
100
More than 1 sample in each individual
Number of samples in each individual:
50
50 people per group
Actual sample size reached:
128
More than 1 sample in each individual
Actual sample size in each individual:
64
64 people per group
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Infertile patients who refer to Imam Hospital in Sari city, after obtaining their consent, are randomly assigned in a one-to-one ratio and enter one of the two endometrial preparation groups. Blocking is done in each group based on age (less than 35 years old and 35 to 40 years old).
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The present study is a single-blind RCT in which the embryologist and data assessor were blind to treatment groups. Therefore, patients were not blinded to comply with ethical issues and gave the patient the right to choose. Moreover, double blinding was not possible due to the intervention method. The doctor and the patient were aware of the intervention procedure.
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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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2024-01-15, 1402/10/25
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Ethics committee reference number
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ir.mazums.imamhospital.rec.1402.125
Health conditions studied
1
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Description of health condition studied
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Frozen embryo transfer in modified natural cycle
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ICD-10 code
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N97.4
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ICD-10 code description
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Evaluation and comparison of clinical pregnancy rate in two methods of endometrial preparation using hormone therapy method and modified natural cycle of in frozen embryo transfer cycle
Primary outcomes
1
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Description
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Clinical pregnancy so that the heartbeat of the fetus can be seen in ultrasound
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Timepoint
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5 weeks after embryo transfer or 8th week of pregnancy
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Method of measurement
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By transvaginal ultrasound
Secondary outcomes
1
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Description
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The rate of chemical pregnancy in which only the pregnancy test is positive (B-hCG> 50 IU/l), but no clinical pregnancy was confirmed on vaginal ultrasound in the 8th week.
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Timepoint
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the 8th week of pregnancy
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Method of measurement
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Laboratory test and transvaginal ultrasound
2
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Description
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Miscarriage rate (loss of clinical pregnancy before the 12th gestational week)
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Timepoint
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before the 12th gestational week
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Method of measurement
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Trans vaginal ultrasound
3
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Description
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implantation rate (IR was defined as the number of gestational sacs determined by sonogram divided by the number of frozen embryos transferred )
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Timepoint
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6th gestational week
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Method of measurement
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transvaginal ultrasound
4
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Description
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ectopic pregnancy rate (EPR) (refers to the presence of a gestational sac outside the uterine cavity)
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Timepoint
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6 to 7th gestational week
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Method of measurement
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Laboratory test and transvaginal ultrasound
5
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Description
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twin pregnancy rate (TPR)
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Timepoint
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the 8th week of pregnancy
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Method of measurement
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transvaginal ultrasound
6
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Description
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ongoing pregnancy (Ongoing pregnancy was defined as a continuation of pregnancy after the 12th week of gestation).
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Timepoint
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after the 12th week of gestation
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Method of measurement
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Abdominal ultrasound
7
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Description
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rates of positive hCG,( positive hCG was defined as B-hCG > 50 IU/l measured 14 days after transfer)
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Timepoint
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14 days after embryo transfer
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Method of measurement
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Laboratory test
8
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Description
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cycle cancelation: in mnc If there were no dominant follicles (follicle diameter ≥ 16 mm) until the 16th day, the cycle was canceled. In hrc, the cycle was canceled if the endometrial thickness was still insufficient after 18 days of estrogen administration.
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Timepoint
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in mnc 16th day cycle and 18th day cycle in hrc
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Method of measurement
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transvaginal ultrasound
9
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Description
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Number of visit(Number of visits from the start of the cycle to embryo transfer)
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Timepoint
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from the start of the cycle to embryo transfer
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Method of measurement
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According to the patient's file
Intervention groups
1
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Description
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Intervention group: Patients in the modified normal cycle (mNC-FET) group underwent transvaginal ultrasound on day 10 to 12 of the menstrual cycle to determine the size of the dominant follicle and thus the ovulation induction time. If the ovulation induction time is not determined on the 12th day, the transvaginal ultrasound is repeated 2 days later. And when a follicle equal to or greater than 18 mm is seen, ovulation is induced by injecting 250 micrograms of r-hCG (6500 IU Ovitrelle). Embryo transfer will be done 5-6 days after ovulation induction, and they will receive 800 mg of micronized progesterone daily for four to five days until the time of embryo transfer, and based on the condition of the frozen embryo, 24-48 hours before the time set for Transfer will melt.
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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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Mazandaran University of Medical Sciences
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Proportion provided by this source
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10
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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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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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Yes - There is 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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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The design protocol, demographic information of the patients, and statistical results will be published as an article after the end of the study
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When the data will become available and for how long
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After publication in one of the authoritative publications
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To whom data/document is available
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Academic centers and infertility researchers
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Under which criteria data/document could be used
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Research exploitation
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From where data/document is obtainable
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Email of researchers and Mazandaran University of Medical Sciences
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What processes are involved for a request to access data/document
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About six months after the end of the study
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Comments
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