FDA Compliance At IVF1

At IVF1, the cornerstone of our relationship with clients is built on trust. We are firmly committed to following the rigorous standards established by the FDA to offer safe and highly effective fertility treatments.

FDA Guidelines for Donors

FDA Guidelines for Egg Donors

  • Physical Health Assessment: Every potential donor at IVF1 undergoes a comprehensive physical examination, ensuring their fitness and readiness for egg donation.
  • Extensive Donor Questionnaire: Donors complete a detailed questionnaire to participate in the process.
  • Thorough Infectious Disease Testing: We employ a strict testing regime for infectious diseases, using an FDA-certified lab. These essential tests occur within 30 days before or 7 days after egg retrieval.
  • Requirements for Anonymous Egg Donors: Anonymous donors must comply with the FDA's tissue eligibility standards.
  • Procedures for Directed Egg Donations: When the donation is from a known donor, the tissue can be used even if it doesn't meet standard criteria, provided it's correctly labeled and consent is obtained as per FDA guidelines.

FDA Standards for Donor Embryos

  • Infectious Disease Screening for Egg and Sperm: IVF1 strives to test both the egg and sperm donors for infectious diseases, including CMV and HTLV types I and II.
  • Use of Ineligible Embryos: Embryos not meeting eligibility criteria can be used with proper labeling and informed consent from recipients.

FDA Protocols for Anonymous Sperm Donors:

  • Donor Health Examination: Each donor undergoes an in-depth health exam to confirm their suitability for sperm donation.
  • Detailed Donor Questionnaire: A comprehensive questionnaire about their medical and personal history is required.
  • Complete Medical History Analysis: A thorough review of the donor's medical history is conducted.
  • Infectious Disease Testing at FDA-Approved Labs: Tests for CMV and HTLV types I and II are carried out within a specific timeframe surrounding sperm collection.
  • Six-Month Sperm Quarantine and Re-testing: Sperm is kept in quarantine for six months, followed by a second round of infectious disease testing.
  • Eligibility for Tissue Use: Donors must meet FDA criteria for tissue usage.

FDA Guidelines for Known Sperm Donors:

  • Health Evaluation: Directed donors also receive a full physical examination.
  • In-Depth Donor Questionnaire: These donors complete a detailed questionnaire about their health and personal background.
  • Infectious Disease Testing: Testing for diseases like CMV and HTLV types I and II is performed within 7 days of sperm collection.
  • Usage of Non-Eligible Tissue: Sperm that doesn't meet eligibility can still be used with appropriate labeling and informed consent.

IVF1 rigorously adheres to all FDA regulations, ensuring the highest safety and compliance standards in our egg donation procedures. For more information, refer to the FDA's guidelines.

Comprehensive Donor Screening and Testing

We conduct thorough medical, genetic, and psychological evaluations of our donors, in line with FDA requirements. This includes extensive infectious disease testing.

FDA Tests for Female Donors Include:

  • CT/NG NAT (Chlamydia/Gonorrhea)
  • HBcAb, Total (Hepatitis B Core Antibody)
  • HBsAg (Hepatitis B Surface Antigen)
  • HCV Ab (Hepatitis C Antibody)
  • HIV-1/HCV/HBV Ultrio NAT
  • HIV-1/2 Plus O EIA
  • T. pallidum, IgG (Syphilis)
  • West Nile Virus, RNA

FDA Tests for Male Donors Include:

  • CMV, Total w/ reflex to IgM/IgG
  • CT/NG NAT (Chlamydia/Gonorrhea)
  • HBcAb, Total w/ reflex to IgM
  • HBsAg w/ reflex to HBV DNA Quant
  • HCV Ab w/ rfx to HCV RNA Quant
  • HIV-1/HCV/HBV Ultrio NAT
  • HIV-1/2 Plus O EIA w/reflex to HIV-1, Quant
  • HTLV I/II Ab
  • T. pallidum, IgG (Syphilis)
  • West Nile Virus, RNA

Exceptional Record-Keeping Practices

IVF1 maintains detailed records of all treatments, donor information, and patient interactions, ensuring transparency and compliance with FDA regulations.

Commitment to Tissue Handling and Preservation

IVF1 employs advanced technology for processing and storing reproductive tissues, following FDA guidelines for quality and safety.

Quality Assurance and Control

Our facilities boast strong quality control systems. Regular audits, staff training, and equipment checks ensure compliance with FDA standards, offering superior care.

Adherence to FDA Labeling and Packaging Requirements

IVF1 strictly follows FDA guidelines for the labeling and packaging of reproductive tissues, ensuring accurate identification and reducing mix-up risks.

Prompt Reporting

We promptly report any adverse events as per FDA regulations, upholding the highest safety standards and contributing to national safety monitoring.

Certification and Regulatory Compliance

IVF1 is registered with the FDA and also adheres to the standards of professional fertility organizations, affirming our commitment to top-tier fertility care.

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Patient Testimonials

Amazing staff. They made us feel like family. They cried when I called to tell them the birth of our daughter. Starting round two next month. Simply the best. They care!

BT Warner

Thanks to Dr.Morris I am holding today my little dream girl. I don't have enough words to express how thankful I am to him and everyone working in IVF1 Naperville. Highly recomend Dr.Morris and his clinic to everyone looking for real professional help and attitude!

Petya Vasilev

Dr. Morris is by far the best fertility doctor! When I transferred to IVF1 from my previous fertility doctor, he read all my medical records in depth. Never once did I feel stressed or unsure of what was happening. The entire staff there is so nice and make you feel so comfortable. It was so easy to schedule appointments, get medications, or ask a nurse a question. My calls were always returned within 20 minutes. I highly recommend IVF1! Dr. Morris made it possible for us to get pregnant!

Lisa

I honestly can’t praise this company enough. Dr. Randy Morris bedside manner is absolutely amazing, his staff professionalism and customer service is also amazing. Your experience with this company will be nothing but perfect. From the initial call to the receptionist. To speaking with the nursing staff, billing, etc. everyone wants to help you with family planning. No matter what my outcome is, I know I’m with a co that will make sure I have the best chances. Thank you to Dr Randy Morris and Staff a bunch!

Misty Johnson

Dr. Morris and staff were very friendly. Dr. Morris was very informative and patient with answering all questions I had. We were uncertain on the options and next steps to take and Dr. Morris explained all the details and options we have. Excellent staff and a great doc.

Jenita Crawford

He is a very professional and good doctor. the whole clinic is very nice. all the staff are amazing. The doctor operated on me for endometriosis and I got pregnant during the second IVF. we have a wonderful 1 year old son. thank you doctor we still have an embryo, I think I will definitely come back to you in a year or two.

Ziva Ru

I’m so grateful to have been referred to Dr. Morris and his team! I’ve spent the last month or so working with the team and they’ve made what is naturally a hard process both mentally and physically as comforting and easy as possible. Dr. Morris’s success rates speak for themselves, but what I want to let everyone know is that he is equally comforting. A special thank you to Jocelyne, Pam and Barbie, these three women on his staff from front desks to RNs really have made the experience an extremely positive one. PS. My cousin who referred me to Dr. Morris has a smart, healthy and beautiful baby boy who he helped bring into this world!

Alex Villa

The staff is amazing here. I’m in the middle of IVF and had an issue with a medication and they went above and beyond to make sure everything was done to continue our journey (on the weekend no less); truly above and beyond. The staff are very caring and professional. Definitely recommend Dr. Morris and this amazing practice.

Megan Buetikofer

I don't even know where to start...THANK YOU! Thank you for giving us our son. We went through a year of IVF. Although there may have been things I didn't want to hear (chances of pregnancy, factors out of our control, etc.) it was important to hear the truth and know what our chances were. The staff was always great with us and they were very patient. They really have everything figured out and what the best options out for outcomes. I never felt pressured to make certain decisions and always felt well informed. Again, I can't thank Dr. Morris and all his staff for everything!!!

Lauren Throm
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