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

NCT03683043 | Unknown Phase 4 DMC

• 1 other identifier: 40
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy rate

  detection of intrauterine gestational sac using transvaginal ultrasound

  14 days after embryo transfer

Study Arms (2)

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

Drug: Long GnRH agonist protocol; Procedure: Embryo transfer

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

Drug: Long GnRH agonist protocol; Procedure: Embryo transfer

Interventions

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.

Also known as: Leuprolide acetate ( Lupron)

Transabdominal guided transfer; Transvaginal guided transfer

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

Transabdominal guided transfer; Transvaginal guided transfer

Eligibility Criteria

• Age: 19 Years - 37 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Infertile female patients aged 20-37 years old undergoing IVF
• Long protocol
• Embryo transfer of fresh cycles D3

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, 12111, Egypt

Location

MeSH Terms

Interventions

Leuprolide; Embryo Transfer

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Ahmed maged, MD

  Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed maged, MD

CONTACT

+2001005227404; prof.ahmedmaged@gmail.com

Noura Alnassery, MD

CONTACT

noura_elnassery2004@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 25, 2018
• Study Start: September 1, 2018
• Primary Completion: September 1, 2019
• Study Completion: October 1, 2019
• Last Updated: September 25, 2018

Record last verified: 2018-09

Locations

EG (1)