Doctor-Selected vs Lab-Selected Sperm for IVF

N/A

Recruiting

Research Sponsored by IVI America

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours post icsi procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial tests how well sperm chosen by a doctor works for IVF compared to sperm chosen by a lab.

Who is the study for?

Couples facing infertility, where the female is under 42 but over 18 years old with normal ovarian reserve and undergoing their first IVF cycle. They must elect single embryo transfer and preimplantation genetic testing for aneuploidy. Exclusions include males with certain genetic abnormalities or those needing surgically obtained sperm.

What is being tested?

The trial compares two methods of selecting sperm for ICSI during IVF: one using zona pellucida-bound sperm and the other using routine embryologist selection to see which method improves pregnancy outcomes.

What are the potential side effects?

While not explicitly stated, typical side effects from IVF procedures can include cramping, bloating, breast tenderness, mood swings, headaches, bruising from shots, allergic reactions to medicines, infection or bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one week after the vaginal oocyte retrieval and icsi procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one week after the vaginal oocyte retrieval and icsi procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and one week after the vaginal oocyte retrieval and icsi procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Blastulation Rate

Secondary study objectives

Blastocyst Ploidy Rate

Fertilization Rate

Sustained Implantation Rates

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: ZP Bound Sperm Selection Oocyte CohortExperimental Treatment1 Intervention

This is half of the patient's mature oocytes that will be inseminated via the ICSI procedure with sperm that has bound to the ZP of an immature oocyte.

Group II: Routine Care: Embryologist Selected Sperm Oocyte CohortExperimental Treatment1 Intervention

This is half of the patient's mature oocytes that will be inseminated via the ICSI procedure per routine with sperm that is subjectively selected by the embryologist (based on morphology and mobility characteristics). This is the current standard of care for ICSI.

Do I qualify?Apply below to find out