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IRCT20220906055898N2 IRCT 2022-10-23 Shiraz University of Medical Sciences Comparing the depth of embryo transfer and its effect on the outcomes of frozen embryo transfer cycles in infertile women applying for frozen embryo transfer Comparing the depth of embryo transfer and its effect on the outcomes of frozen embryo transfer cycles: a double-blind RCT 2022-10-11 anticipated 204 Complete https://irct.ir/trial/66156 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, firstly, the samples were selected based on the conditions for entering the study and based on the goal, after equalizing the demographic characteristics (age, education, and the number of previous unsuccessful transfers), among the women who were referred to Hazrat Zainab infertility treatment center for transfer. The frozen embryos that have referred themselves are selected by an easy and accessible sampling method. 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 intervention groups: low catheter depth, medium catheter depth, and high catheter depth. All patients are included in the study voluntarily and with the knowledge of random assignment of the intervention. It will be explained to all the participants before the start of the study that they will be randomly divided into three intervention groups of embryo transfer at a shallow depth of the uterine fundus (A), medium depth of the uterine fundus (B), and deep depth of the uterine fundus (C). will be used to randomly divide the samples using the block random allocation method. 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 (software allocation Random), which in addition to simple randomization, these random sequence generation software is capable of generating random sequences by the 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. In such a way that the assigned group is not known before assigning the individual. By using sealed opaque letter envelopes with a random sequence (Sequentially numbered, seale, opaque envelope), 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. After being a candidate for embryo transfer; 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, blinding is done in a double-blind manner, so the researcher will perform the embryo transfer at the specified depth for each patient using the codes given by the epidemiologist, and the patients are blinded to the embryo transfer depth. Groups and data will be coded, and the statistician analyzing the data will be blinded to the type of grouping and group information. 3 Infertility. Intervention 1: Intervention group: All patients, with or without suppuration, receive estradiol orally at a dose of 4-6 mg from the second or third day of the menstrual cycle, and after transvaginal ultrasound, the endometrium thickness is good and sufficient for embryo transfer. and then the embryos are transferred in the stage of cleavage or blastocyst. Intervention 2: Intervention group: In the first intervention group, embryo transfer will take place at a depth of 0.5 to 1.5 cm. Intervention 3: Intervention group: In the second intervention group, embryo transfer will take place at a depth of 1.5 to 2.5 cm. Intervention 4: Intervention group: In the third intervention group, embryo transfer will take place at a depth of 2.5 to 3.5 cm. 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 I haven't decided yet.
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 s.kharati@yahoo.com Shiraz University of Medical Sciences scientific Ameneh Keshavarzi
Department of Obstetrics and Gynecology, Shahid Faghihi Hospital, Zand St, Shiraz, Iran
Shiraz Iran (Islamic Republic of) 3478671946 +98 71 3233 2365 s.kharati@yahoo.com Shiraz University of Medical Sciences Iran (Islamic Republic of) • Candidate patients for embryo transfer between 20 and 45 years old • Patients with at least two good quality embryos for transfer • Patients with normal BMI • Patients with a healthy uterine cavity confirmed by hysterosalpingograph and hysteroscope or ultrasound. 20 years 45 years Female • Patients with uncontrolled chronic disease • Patients with donated eggs or embryos • Patients with surrogacy • Poor responder • Patients with endometriosis problems • Non-use or irregular use of medicines • Patients with a history of more than three unsuccessful transplants (RIF) • Presence of hydrosalpinx • Patients with endometrial thickness less than 7 mm after HRT • Patients with adenomyosis • Patients whose embryos are the result of TESE or severe male factor • PGD candidate patients N97 Female infertility Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: All patients, with or without suppuration, receive estradiol orally at a dose of 4-6 mg from the second or third day of the menstrual cycle, and after transvaginal ultrasound, the endometrium thickness is good and sufficient for embryo transfer. and then the embryos are transferred in the stage of cleavage or blastocyst. Intervention group: In the first intervention group, embryo transfer will take place at a depth of 0.5 to 1.5 cm. Intervention group: In the second intervention group, embryo transfer will take place at a depth of 1.5 to 2.5 cm. Intervention group: In the third intervention group, embryo transfer will take place at a depth of 2.5 to 3.5 cm. Biochemical pregnancy rates. Timepoint: 2 weeks and 6 weeks after embryo transfer. Method of measurement: Through B-HCG test and transvaginal ultrasound. Clinical pregnancy rate. Timepoint: 2 weeks and 6 weeks after embryo transfer. Method of measurement: Through B-HCG test and transvaginal ultrasound. Pregnancy. Timepoint: 2 weeks after embryo transfer. Method of measurement: By transvaginl sonography. Shiraz University of Medical Sciences Approved 2022-09-11 Ethics Committee of Shiraz University of Medical Sciences Headquarters Of Shiraz University of Medical Sciences - Zand St - Shiraz Shiraz Fars Iran (Islamic Republic of)