3rd Party reproduction Flashcards
Third Party Reproduction (TPR)”
The phrase “third party reproduction” refers to the use of eggs, sperm or embryos that have been donated by a third person (donor) to enable an infertile individual or couple (intended parent/recipient) to become parents.
What type of cycle is considered TPR?
Donated reproductive tissue (eggs or sperm) are regulated as human cells, tissues, and cellular and tissue-based products (HCT/Ps)
Strict guidelines/regulations
FDA-inspections/audits
ASRM
Clinic
Screening tests
FDA (Food and Drug Administration)
Laboratory testing must be sent to FDA compliant lab (LabCorp->Viromed)
Blood/Urine testing
History & Physical Exam for gamete donor
Screening Questionnaire
ASRM (American Society of Reproductive Medicine)
Psychological screening of all parties
Individual and Joint consults, as applicable
Clinic (Spring Fertility)
Legal Contract ->Intended Parent (IP) & Egg donor and/or GC
Pretreatment screening per treatment type/gamete donor or recipient
GC & their partner- records review, screening tests
FDA screening requirements
FDA publishes guidelines on all tissue donation (ie. Bone, skin, cornea, etc..)
Their three rules are to prevent the introduction, transmission and spread of communicable disease.
Clinic must register with FDA to offer this service
Evaluate donors with screening/testing
Tissue recovered, after 2005, have additional guidelines to improve protection of public health while minimizing regulatory burden
FDA screening
Within 6 months of tissue donation:
Questionnaire
Physical Exam
Within 30 days of tissue donation:
Egg donor: Expanded STD blood & urine test sent to FDA approved lab
Within 7 days of tissue donation/freeze:
Sperm: Expanded STD blood & urine test sent to FDA approved lab
Donor Eligibility Determination (DED)
Required to ensure tissue labeling is correct by the Embryology team (Eligible/Ineligible)
Required to inform of risks in having donated tissue transferred
Reviewed in FDA audits
Psychological Screening
Egg/Sperm Donors
Gestational Carriers (GC)
Intended parents (ASRM)
Legal Requirements
A contract should be established between the intended parents and the donor/GC to ensure protection for both parties and their children
Donor Sperm-Nonidentified
Nonidentified Sperm
Sperm bank resp. for FDA & all screening (only eligible donors)
Genetic screening varies, per donor/bank
Order 2 vials sperm/treatment cycle
Spring tissue bank coordinator assists
Cytomegalovirus (CMV)
Common virus, affects all ages
Most asymptomatic, some healthy people can experience fever, sore throat, fatigue, swollen glands.
Those with weakened immune systems can have more serious symptoms affecting eyes, lungs, liver, esophagus, stomach, intestines
Babies born with CMV can have brain, liver, spleen, lung, and growth problems. Most common long-term health condition is hearing loss.
Donor Sperm-Identified or Directed
Identified Sperm Donor (ISD)
Initial Screening
SA, IDTs, Carrier Screening (optional), pre-screening FDA questionnaire
FDA Screening (Quest/PE/FDA blood/urine test)
Within 7 days, schedule sperm cryo
Ineligible, IP may have option to sign waiver and proceed
CMV & Sperm Donors
CM
V status disclosed for sperm donors
Ineligible to donate if IgM +
Intended recipient/carrier’s CMV status needed to inform risk and determine if a waiver might be necessary
IgM (+) potential active infection
IgG (+) potential previous exposure / immunity
IgM (-) IgG (-) no history of infection
Egg Donor Qualifications
<29 years old
BMI 19-29 (max BMI varies per agency/clinic)
Non-smoker
Regular, monthly periods
Have both ovaries
Physically + Psychologically healthy
No STI past year
No recreational drug use
No more than 6 egg donation cycles/lifetime (ASRM)
Egg Donor Selection
Fresh vs Frozen Eggs
Spring Nest Bank vs. Outside Bank
Nonidentified or Directed (Identified)Egg Donor (Local or Out of State)
OD Screening
Carrier screening (gamete contributor)
Psychological
IDTs (Standard)
Recommend Sperm cryopreservation (convenience)
Fresh Egg/Ovum Donor
IP selects Egg donor
Nest or Outside Agency
OD compensation per cycle ~8K
IP pays all fees for screening, compensation, donor travel (if indicated)
Initial Screening tests (OD)
Carrier screening, Psych, Karyotype, Questionnaire, optional genetics consult
If initial screening satisfactory
Complete testing-FDA, Ovarian assessment, Spectrum (if PGT-A)
Repeat FDA lab panel needed within 30 days of egg retrieval
Spring’s Nest Donors
Frozen egg bank
One & Two Blast guarantee
Single & Multiple Cohorts
Egg Share Program
Eligible women can donate some eggs & keep some for future
Cost of cycle covered & 3 years storage or until age 30 included
Fresh Ovum Donor in treatment
Highly recommend Spring Medication package
IP notified:
Each monitoring visit
Retrieval
Fert/Embryo reports
No donor info shared—only Donor #
Gestational Carrier Qualifications
Agencies Recruit Candidates
General Requirements
Age: 21-40 at the time of embryo transfer
Max BMI: 30
Must have at least 1 child
Max C-sect deliveries: 2, no more than 4 total deliveries
Min time since previous deliver: 1 year
GC Screening
Initial Screening
Psych
Initial FDA Questionnaire
Sexually intimate male partner (FDA bloodtests)
If satisfactory
Final Questionnaire
H&P, SIS, FDA bloodtests + Preconception panel & urine toxicology
GC to repeat FDA screening within 30 days of embryo transfer
DED completed prior to transfer
Gestational Carrier in treatment
Most common-> Controlled FET
Can be Fresh OD or IP stim, with transfer into GC
IP(s) updated after all monitoring
IP/GC called with bHCG
IP(s) can attend appts/transfer/Pregnancy US,
Reciprocal IVF
S/S, trans/non-binary couple
One partner donates eggs, the other partner carries the pregnancy
No FDA testing requirements needed, they are sexually intimate couple
setting up starting
mentally rehearse and arrange for privacy
spikes
setting up and starting, perception, invitation, knowledge, emotions, strategy and summary
perception
elicit the pt’s perspective
invitiation
ask the pt what they would like to know
knowledge
provide info in small pieces - give an idicator first - speak in a tone that the news might be disappointing
emotions
recognize and empathize w/ the pt’s emotions
strategy and summary
set out a medical plan of action
