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IRCT20170315033085N5 IRCT 2021-03-23 Mashhad University of Medical Sciences Effect of Nigella Sativa capsules on preparation of endometrium for frozen embryo transfer cycles Effect of Nigella Sativa capsules in order to prepare endometrium for frozen embryo transfer 2021-04-09 anticipated 116 Complete https://irct.ir/trial/55108 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with table of random numbers available at ''www.randomization.com'' website will be used. Numbers will be placed in sealed envelopes and each envelope is assigned to one participant placing them in one of the two groups, Blinding description: This study is a single blinded clinical trial. Based on the random codes generated, participants are assigned to one of these two groups. Participants are not aware of the type of grouping and received treatment. 2-3 Decreased or lack of fertility in a woman of childbearing age. Intervention 1: Intervention group: In this group, patients are prescribed one Nigella Sativa capsule each night in the first 7 days of menstruation and then one in the morning and one at night until the endometrium is ready. Intervention 2: Control group: In this group, patients are prescribed estradiol 2mg tablets with a dose of 4 mg in the first 7 days of menstruation and then with a dose 6 mg until the endometrium is ready. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. When: Data can be accessible 6 months after results are published. To whom: Data can be accessible through an email to the corresponding author. Conditions: Data will be available for researchers in universities and other scientific institutes. Where to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. How to obtain: Carrying out analysis on data is permitted. Comments:
public Dr. Malihe Afiat
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2406 afiatm@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Malihe Afiat
Imam Reza Hospital, next to Imam Reza square, Ibne Sina street
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3802 2406 afiatm@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Women between 20 and 42 years old with a frozen fetus who are candidate for embryo transfer 20 years 42 years Female Allergy to herbal medicines and specifically Nigella Sativa N97.9 Female infertility, unspecified Treatment - Drugs Treatment - Drugs Intervention group: In this group, patients are prescribed one Nigella Sativa capsule each night in the first 7 days of menstruation and then one in the morning and one at night until the endometrium is ready. Control group: In this group, patients are prescribed estradiol 2mg tablets with a dose of 4 mg in the first 7 days of menstruation and then with a dose 6 mg until the endometrium is ready. Endometrial thickness. Timepoint: Third, tenth, twelfth, and fourteenth day of the cycle. Method of measurement: Transvaginal ultrasound. Fertility rate. Timepoint: Two weeks after embryo transfer. Method of measurement: Beta HCG test. Implantation rate. Timepoint: 35 days after embryo transfer and 7 days after a positive result on pregnancy test. Method of measurement: Transvaginal ultrasound. Subclinical pregnancy. Timepoint: 14 days after embryo transfer. Method of measurement: Beta HCG test. Clinical pregnancy. Timepoint: 42 days after embryo transfer. Method of measurement: Transvaginal ultrasound. Live birth rate. Timepoint: after delivery. Method of measurement: live fetus delivery after 28 weeks of gestational age. Mashhad University of Medical Sciences Approved 2020-10-18 Ethics Committee of Mashhad University of Medical Sciences Central Building of Mashhad University of Medical Sciences (Ghorshi), Daneshgah 16, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)