MedTrace Logo

Prospective, Randomized Trial Comparing ICSI to Insemination for Non-Male Factor Patients Undergoing PGT-A

NCT05548101 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2022-09-21

No results posted yet for this study

Summary

Intracytoplasmic sperm injection (ICSI) is a procedure performed during in vitro fertilization (IVF) in which a single sperm is injected directly into an oocyte. This procedure was developed for male factor infertility due to its requirement for a very small number of viable sperm. However, its use has expanded and is now recommended for IVF cycles in which preimplantation genetic testing for aneuploidies (PGT-A) is performed on blastocysts. We hypothesize that the ICSI procedure may interfere with the normal meiosis II process that occurs during fertilization, and lead to a higher rate of aneuploid blastocysts. In our study we will randomly assign non-male factor infertility patients to either conventional insemination or ICSI and compare the rate of karyotypically normal embryos in each group.

Conditions

Interventions

PROCEDURE

ICSI

Using the injecting pipet, one sperm will be isolated. Using the tip of the injecting pipet, the sperm tail will be broken by trapping it between the pipet and bottom of the dish. The sperm will be picked up in the pipet. The oocyte will be positioned so the polar body is at the 12 o'clock or 6 o'clock position. The sperm injecting pipet will be positioned at the 3 o'clock position of the oocyte. The injecting pipet will be advanced into the oocyte cytoplasm and the cytoplasm will be gently aspirated until the oocyte membrane breaks. The sperm will then be injected into the cytoplasm of the oocyte. The pipet will then be withdrawn from the oocyte.

Sponsors & Collaborators

  • Ovation Fertility

    collaborator OTHER

  • Texas Fertility Center

    lead OTHER

Principal Investigators

  • Kaylen Silverberg, MD · Texas Fertility Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-11-01
Completion
2023-11-01

More Related Trials

Entities

Diseases

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 NCT05548101 on ClinicalTrials.gov