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IRCT20210510051249N1 IRCT 2021-08-25 Mashhad University of Medical Sciences The effect of counseling on perceived stress, number of ‎oocytes retrieved and pregnancy rates ACT The effect of counseling based on acceptance and commitment consulting on perceived stress, number of ‎oocytes retrieved and pregnancy rates in infertile women undergoing IVF treatments 2021-09-06 anticipated 76 Complete https://irct.ir/trial/56360 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Sampling is available by simple random assignment. After determining the sample size, through a table of random numbers using the statistical software Random allocation software, the numbers are divided into two groups of sequences marked with the letters A and B. The sequence stored in sealed envelopes that the researcher uses when selecting a research unit to send individuals to two groups that meet the inclusion criteria. N/A The effect of counseling based on acceptance and commitment consulting on perceived stress number of ‎oocytes retrieved and pregnancy rates in infertile women undergoing IVF treatments. Intervention 1: The intervention group will receive six sessions of 45-60 minutes, counseling based on acceptance and commitment individually, the first session of day 2 to 3 of the first cycle (after basic ultrasound) in person and the rest of the sessions in absentia every six days ( Day 8- 14-20-26 The first cycle and the last session will be run on days 2 to 3 of the next virtual cycle. Intervention 2: Control group: In the first session, the control group completes the questionnaires and provides the routine services of the center, which include explanations about IVF treatment and possible complications and costs for treatment, to decide on treatment. On day 2-3 of the cycle, measures including basic ultrasound and initial tests are requested and then 21 units of subcutaneous ampoules of Cinnafact are prescribed daily for 0.5 units, and they are taught how to use infertility drugs and the time of their next visit. Second, HMG 150-300 units are added daily depending on the ovarian reserve under the supervision of an infertility specialist and 6 days after the onset of ovarian stimulation, folliculography is performed every two to three days, until at least 3 dominant 17 mm follicles are observed. HCG is triggered and ovulation will occur 36 hours later. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Toktam taheri
University Street, Ph.D. Crossroads, School of Nursing and Midwifery
Mashhad Iran (Islamic Republic of) 9189835486 +98 51 3859 1511 taherits971@mums.ac.ir Mashhad University of Medical Sciences scientific Nahid Jahani Shorab
School of Nursing and Midwifery, Ibn Sina St., Doctora Intersection, Daneshgah St., Mashhad, Khorasan Razavi, Iran
Mashhad Iran (Islamic Republic of) 9137913199 +98 51 3859 1511 jahanishn@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Diagnosis of primary infertility, Iranian and resident of Mashhad, ability to speak and write in Persian, no known medical diseases, age between 20 to 40 years, couple have no children or adopted children, no mental illness, IVF treatment for For the first time, in the basic ultrasound (day 2 to 3 of the cycle) the ovary has a normal appearance to start treatment, the spermogram is normal, the husband has no other spouse, no smoking and alcohol consumption, BMI is below 30, IVF candidate, has Smartphone and consent to participate in the study 20 years 40 years Female Intend to use embryos and donated eggs or surrogates Behavior Behavior The intervention group will receive six sessions of 45-60 minutes, counseling based on acceptance and commitment individually, the first session of day 2 to 3 of the first cycle (after basic ultrasound) in person and the rest of the sessions in absentia every six days ( Day 8- 14-20-26 The first cycle and the last session will be run on days 2 to 3 of the next virtual cycle Control group: In the first session, the control group completes the questionnaires and provides the routine services of the center, which include explanations about IVF treatment and possible complications and costs for treatment, to decide on treatment. On day 2-3 of the cycle, measures including basic ultrasound and initial tests are requested and then 21 units of subcutaneous ampoules of Cinnafact are prescribed daily for 0.5 units, and they are taught how to use infertility drugs and the time of their next visit. Second, HMG 150-300 units are added daily depending on the ovarian reserve under the supervision of an infertility specialist and 6 days after the onset of ovarian stimulation, folliculography is performed every two to three days, until at least 3 dominant 17 mm follicles are observed. HCG is triggered and ovulation will occur 36 hours later. Stress score. Timepoint: The beginning of the study (before the intervention) and the trigger day (two weeks after the last consultation) and two weeks after the embryo transfer. Method of measurement: Newton Infertility Stress Questionnaires. Follicle number. Timepoint: Number of ovarian follicles at trigger time with HCG. Method of measurement: With ultrasound by a gynecologist. Pregnancy rates. Timepoint: Two weeks after embryo transfer. Method of measurement: blood test. Mashhad University of Medical Sciences Approved 2021-06-15 Ethics committee Mashhad University of Medical Sciences and Health Services Opposite to University Street 18, University Street, Mashhad University of Medical Sciences, Khorasan Razavi, Iran Mashhad Razavi Khorasan Iran (Islamic Republic of)