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Comparative Study Between ICSI Results in Transvaginal Ultrasound Guided Embryo Transfer and Transabdominal Ultrasound Guided Embryo Transfer

NCT03683043 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-09-25

No results posted yet for this study

Summary

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.

Conditions

  • Invitro Fertilization

Interventions

DRUG

Long GnRH agonist protocol

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.

PROCEDURE

Embryo transfer

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

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Ahmed maged, MD · Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
37 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2019-09-30
Completion
2019-10-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03683043 on ClinicalTrials.gov