Comparing the depth of embryo transfer and its effect on the outcomes of frozen embryo transfer cycles: a double-blind RCT

Comparing the depth of embryo transfer and its effect on the outcomes of frozen embryo transfer cycles

204 women applying for the transfer of gynecological freeze, referring to Hazrat Zainab infertility treatment center and meeting the entry requirements, will be included in the study; All patients, with or without suppuration, receive oral estradiol at a dose of 4-6 mg from the second or third day of the menstrual cycle, and after the transvaginal ultrasound, the thickness of the endometrium is good and sufficient for embryo transfer, they are candidates for embryo transfer; After homogenization of patients in terms of demographic and clinical characteristics, people will be divided into three groups by random allocation of blocks. In this study, all patients are blinded. In the first group, embryo transfer at a depth of 0.5 to 1.5 cm, in the second group, embryo transfer at a depth of 1.5 to 2.5 cm, and in the third group, embryo transfer at a depth of 2.5 to 3.5 cm. (embryos are transferred in the cleavage or blastocyst stage) will take placeFinally, after 2 weeks, the result of chemical pregnancy will be checked using the B-HCG test, and after 6 weeks, the result of clinical pregnancy

infertility treatment center of Zainab Hospital in Shiraz

Patients aged 20 to 45 years; Patients with at least two good quality embryos for transfer; Patients with healthy uterine cavity confirmed by hysterosalpingography and hysteroscopy or saline ultrasound.

This study includes 3 groups of 68 people. Embryo transfer in the first group at a depth of 0.5 to 1.5 cm from the uterine fundus, in the second group embryo transfer at a depth of 1.5 to 2.5 cm from the uterine fundus, and in the third group embryo transfer at a depth of 2.5 to 3.5 cm from the uterine fundus will be done

pregnancy

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.

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.