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This prospective study will be conducted on 120 patients candidates for ICSI cycle and following the long protocol for controlled ovarian stimulation; the patients were randomly allocated in a 1:1 ratio to either group A; where the embryo transfer was assisted by transabdominal ultrasound and group B; where the embryo transfer was assisted by Transvaginal ultrasound. The study nurse opened the sealed envelopes according to sequence of attendance of patients to allocate patients to the assigned group. Both the patient and the operator were blind to the assigned group.
All the transfers were done on day 3 after OPU for at least 2 grade I embryos using the Edwards-Wallace embryo replacement catheter using the same ultrasound device. Quantitative serum hCG test was done for all patients 14 days after the transfer.
One hundred and twenty patients were randomly allocated to either the trans-abdominal guided embryo transfer group (n= 60) or the transvaginal guided embryo tranfer group ( n = 60) . The investigators used a computer generated randomization table obtained from http://graphpad. com/quickcalcs/randomize1 and sequentially numbered sealed opaque envelopes to randomize the patients to the study groups. The allocation information was written on a card placed in the sealed envelopes. A colleague (who was not directly involved in the study) prepared the randomization table and the sealed envelopes.The patients were blind to the assigned group. The gynecologists were as well blind to the received treatment.
Patients included in the study are consenting to controlled ovarian hyperstimulation protocol, folliculometery visits, ovarian stimulation medications, ovum pick up, embryo transfer, luteal phase support, possible complications, as well as consenting to disclosure of pregnancy test results 14 days after embryo transfer.
After obtaining an informed written consent, each patient will be submitted to the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transabdominal guided transfer | Active Comparator | In the trans-abdominal guided embryo transfer group, the patients' bladder were filled by 500-700 ml saline; in order to enhance the visualization. The trans-abdominal probe is applied on pelvis by an assistant nurse or the attending gynecologist intern |
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| Transvaginal guided transfer | Active Comparator | the trans-vaginal guided embryo transfer group had their bladder emptied by the gynecologist via catheter prior to transfer or else the patient was asked to void. The speculum is applied followed by insertion of the outer sheath of the transfer catheter. The speculum is removed with caution; to maintain the outer sheath in place. The TVUS probe is applied vaginally and endometrium is visualized before transfer. The transfer is done through an inner catheter applied to the already inserted outer sheath |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long GnRH agonist protocol | Drug | 8. The patients follow long protocol, which includes down regulation starting on day 21 of the previous cycle. The patient is seen after 14 days to confirm down regulation. Serum E2 ≤ 50 pg/ mL and no ovarian cysts observed in transvaginal US. 9. Induction is started on day 3 of the current cycle by gonadotrophins (FSH and LH) daily IM or SC injections provided that the different preparations at the market can be used. |
| Measure | Description | Time Frame |
|---|---|---|
| clinical pregnancy rate | detection of intrauterine gestational sac using transvaginal ultrasound | 14 days after embryo transfer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ahmed maged, MD | Contact | +2001005227404 | prof.ahmedmaged@gmail.com | |
| Noura Alnassery, MD | Contact | noura_elnassery2004@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed maged, MD | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Alainy medical school | Cairo | 12111 | Egypt |
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| Embryo transfer | Procedure | Cusco speculum was used to allow access to the cervix. The vagina was flushed by saline, and the cervical mucus is removed by Q-tips and/ or suction tubes. In few cases, where patients had long vaginae; two Sims' speculums were used to spread the vaginal anterior and posterior vaginal walls apart. In these cases, the attending nurse assisted the gynecologists during transfer The gynecologist asks the embryologist to load the embryos in the transfer catheter, and the gynecologist receives the loaded catheter from a window connecting the lab and operating room. In cases of trans-vaginal ultrasound guided embryo transfer the embryologist hands in the catheter to the gynecologists in the outer sheath and the gynecologist injects slowly the fluid containing the embryo/s. All patients are asked to rest for 30 minutes after the transfer |
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| ID | Term |
|---|---|
| D016729 | Leuprolide |
| D004624 | Embryo Transfer |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
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