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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
Study 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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Blastulation Rate
Secondary outcome measures
Blastocyst Ploidy Rate
Fertilization Rate
Sustained Implantation Rates
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.
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Who is running the clinical trial?
IVI AmericaLead Sponsor
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My female partner is between 18 and 42 years old.I cannot undergo IVF due to health reasons.My male partner does not have a normal XY chromosome pattern.My uterus lining is too thin or I have persistent fluid in my uterus.My fertility tests show normal ovarian function.I need genetic testing for my embryo due to a risk of specific genetic disorders.My male partner has a genetic issue with his Y-chromosome.I have untreated blocked fallopian tubes that affect my uterus.My male partner has very low or no sperm count.My male partner needs surgery to obtain sperm for conception.I am choosing genetic testing for my embryos before implantation.
Research Study Groups:
This trial has the following groups:- Group 1: ZP Bound Sperm Selection Oocyte Cohort
- Group 2: Routine Care: Embryologist Selected Sperm Oocyte Cohort
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What characteristics make someone an appropriate candidate for this trial?
"Candidates between 18 and 41 years old with documented infertility are eligible to enroll in this clinical trial which is looking for 200 participants."
Answered by AI
Are individuals over the age of 35 permitted to participate in this research project?
"The terms of eligibility for this medical trial are between the ages of 18 and 41. For those younger than 18, there is a total of 11 trials they can take part in while 39 clinical studies exist for participants over 65 years old."
Answered by AI
Is the research team recruiting participants for this experiment?
"Evidently, this clinical trial is not presently enrolling patients. Its initial advertisement was posted on June 1st 2023 and last modified on May 12th of the same year. Nevertheless, there are still 245 other research projects that are actively seeking participants at present."
Answered by AI
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