Skip to content

Trial · Interventional

Status unknownPhase 4Registry data

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

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
120 participants (estimated)
Sponsor
Cairo University · Other
Design
Randomized · Single masking
Countries
1 country

Egypt

Start
Sept 2018 (estimated)
Primary completion
Sept 2019 (estimated)
Completion
Oct 2019 (estimated)
First posted
25 Sept 2018
Last update posted
25 Sept 2018
Conditions
Invitro Fertilization

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201820192020
  1. Ph 4

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

    NCT03683043

    est. Sept 2018 to est. Oct 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Long GnRH agonist protocolDrug
  • Embryo transferProcedure

Arms2

  • Active comparator

    Transabdominal guided transfer

    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

  • Active comparator

    Transvaginal guided transfer

    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

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. clinical pregnancy rate

    Time frame · 14 days after embryo transfer

    Registry description

    detection of intrauterine gestational sac using transvaginal ultrasound

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 19 Years up to 37 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Infertile female patients aged 20-37 years old undergoing IVF * Long protocol * Embryo transfer of fresh cycles D3 Exclusion Criteria: * Uterine abnormalities e.g. sub-mucous fibroid, or fibroids indenting the endometrium, polyps, Ashermann, etc. * Poor responders * Female patients ˃35 years old * Medical disorders e.g. DM, HTN * Immunological disorders e.g. SLE, APS * Cervical distortions * Thyroid or adrenal dysfunction * Endometriosis grade 3 or 4

PepBank is a research reference. Talk to a doctor before you use any peptide.