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IRCT20220906055898N1 IRCT 2022-09-28 Shiraz University of Medical Sciences Comparing the effectiveness of estradiol administration on endometrial thickness and pregnancy outcome in infertile women applying for frozen embryo transfer Investigating the effect of estradiol administration duration on pregnancy outcomes of frozen embryo transfer cycles: a double-blind randomized clinical trial 2022-09-22 anticipated 219 Complete https://irct.ir/trial/65794 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Randomization description: In this study, firstly, the samples were selected based on the conditions for entering the study and based on the purpose, from among the women referring to the infertility treatment center of Hazrat Zainab (PBUH) who referred to transfer their frozen embryos using the easy sampling method and in available are selected. After that, the researcher obtains the informed consent form by referring to the selected people and introducing himself and briefly stating the type of study and the objectives of the study; Then the women participating in the study are randomly assigned to three short-term, medium-term and long-term intervention groups. All patients are included in the study voluntarily and with the knowledge of random assignment of the intervention. It will be explained to all participants before the start of the study that they will be randomly divided into three intervention groups: short-term (A), medium-term (B) and long-term (C) to randomly divide the samples using the random block allocation method. Bandi is used. In this trial, we will have three groups of 6 blocks (including 2 people participating in drug group A, 2 people participating in drug group B, and 2 people participating in drug group C). The randomization tool is also used from random sequence generation software (random allocation software), which in addition to simple randomization, these random sequence generation software are capable of generating random sequence by block method. The randomization process is done by the study methodology consultant and the clinical researchers are not aware of the randomization process. For concealment, we use Concealment Allocation, which refers to the method used to perform a random sequence on the participants in the study, in such a way that the allocated group is not known before the allocation of the individual. By using sealed opaque letter envelopes with a random sequence (Sequentially numbered, seale, opaque envelopes (, in this method, each of the random sequences created is recorded on a card and the cards are placed inside the letter envelopes in order. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At least one week after starting estradiol and when the thickness of the endometrium is 7 or higher; Participants, based on the order of entry of eligible participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed, Blinding description: In this study, after selecting the patients, none of the sample will know about the randomization and allocation process to the groups, and the patients will not have contact with each other and will be visited at separate times. Doctors are given envelopes with coded numbers in advance and patients are entered into study groups in the order of the envelope numbers. Therefore, the present study is double-blind. After receiving estradiol from the second or third day of the menstrual cycle for one week, the patients are divided into three groups receiving progesterone: A- from day 8-11 B- from day 12-14 C- from day 15-18. The doctor who performs the embryo transfer on the day of the end of receiving progesterone does not know which group the patients are in, and only the supervisor of this proposal manages the day of the transfer. 3 Infertility. Intervention 1: Intervention group: All patients are given oral estradiol at a dose of 4 to 6 mg from the second or third day of the menstrual cycle, and after a week, the patients return for the first transvaginal ultrasound to measure the thickness of the endometrium; If the thickness of the endometrium is 7 and above, and suitable, they are divided into three groups in the form of two blind strains. Intervention 2: Intervention group: In the first intervention group, from day 8-11 of receiving estradiol, after measuring the level of estradiol, if there is a suitable response, progesterone is started, and then the embryos are transferred in the cleavage or blastocyst stage. Intervention 3: Intervention group: In the second intervention group, from day 12-14 of receiving estradiol, after measuring the level of estradiol, if there is a suitable response, progesterone is started, and then the embryos are transferred in the cleavage or blastocyst stage. Intervention 4: Intervention group: In the third intervention group, from day 15-18 of receiving estradiol, after measuring the level of estradiol, if there is a suitable response, progesterone is started, and then the embryos are transferred in the cleavage or blastocyst stage. 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 Not specified
public Ameneh Keshavarzi
Department of obstetrics and gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3230 5410 a.keshavarzi2877@yahoo.com Shiraz University of Medical Sciences scientific Ameneh Keshavarzi
Shiraz University of Medical Sciences
Shiraz Iran (Islamic Republic of) 7134814336 +98 71 3230 5410 a.keshavarzi2877@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) • Patients under 45 years of age • Normal BMI • Patients with at least two good quality embryos for transfer • Patients with a healthy uterine cavity confirmed by hysterosalpingograph and hysteroscope or saline ultrasound 20 years 45 years Female Patients with Uncontrolled Chronic Disease Patients with Donated Ovum or Embryos Patients with surrogacy Patients who Could Not Achieve an Endometrial Thickness of 7 to 10 mm Patients with More Than Three Unsuccessful Transplants (RIF) Poor Responder Patients with Endometriosis Patients with Adenomyosis Patients whose Embryos are the Result of TESE or Severe male PGD candidate patients N97 Female infertility Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: All patients are given oral estradiol at a dose of 4 to 6 mg from the second or third day of the menstrual cycle, and after a week, the patients return for the first transvaginal ultrasound to measure the thickness of the endometrium; If the thickness of the endometrium is 7 and above, and suitable, they are divided into three groups in the form of two blind strains. Intervention group: In the first intervention group, from day 8-11 of receiving estradiol, after measuring the level of estradiol, if there is a suitable response, progesterone is started, and then the embryos are transferred in the cleavage or blastocyst stage. Intervention group: In the second intervention group, from day 12-14 of receiving estradiol, after measuring the level of estradiol, if there is a suitable response, progesterone is started, and then the embryos are transferred in the cleavage or blastocyst stage. Intervention group: In the third intervention group, from day 15-18 of receiving estradiol, after measuring the level of estradiol, if there is a suitable response, progesterone is started, and then the embryos are transferred in the cleavage or blastocyst stage. • Biochemical and clinical pregnancy rates. Timepoint: • 2 weeks after embryo transfer. Method of measurement: • By doing the B-HCG test• By transvaginl sonography. Pregnancy. Timepoint: • 2 weeks after embryo transfer. Method of measurement: • By transvaginl sonography. Shiraz University of Medical Sciences Approved 2022-07-31 Ethics Committee of Shiraz University of Medical Sciences شیراز - خیابان زند - ساختمان مرکزی دانشگاه علوم پزشکی شیراز Shiraz Fars Iran (Islamic Republic of)