3rd Party reproduction

Question 1

Third Party Reproduction (TPR)”

Answer 1

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.

Question 2

What type of cycle is considered TPR?

Answer 2

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

Question 3

Screening tests

Answer 3

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

Question 4

FDA screening requirements

Answer 4

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

Question 5

FDA screening

Answer 5

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

Question 6

Psychological Screening

Answer 6

Egg/Sperm Donors​

Gestational Carriers (GC) ​

Intended parents (ASRM)

Question 7

Legal Requirements

Answer 7

A contract should be established between the intended parents and the donor/GC to ensure protection for both parties and their children

Question 8

Donor Sperm-Nonidentified

Answer 8

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

Question 9

Cytomegalovirus (CMV)

Answer 9

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.

Question 10

Donor Sperm-Identified or Directed

Answer 10

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

Question 11

CMV & Sperm Donors

Answer 11

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

Question 12

Egg Donor Qualifications

Answer 12

<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)

Question 13

Egg Donor Selection

Answer 13

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)

Question 14

Fresh Egg/Ovum Donor

Answer 14

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

Question 15

Spring’s Nest Donors

Answer 15

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

Question 16

Fresh Ovum Donor in treatment

Answer 16

Highly recommend Spring Medication package​

IP notified:​

Each monitoring visit​

Retrieval​

Fert/Embryo reports​

No donor info shared—only Donor #

Question 17

Gestational Carrier Qualifications

Answer 17

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

Question 18

GC Screening

Answer 18

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

Question 19

Gestational Carrier in treatment

Answer 19

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,

Question 20

Reciprocal IVF

Answer 20

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

Question 21

setting up starting

Answer 21

mentally rehearse and arrange for privacy

Question 22

spikes

Answer 22

setting up and starting, perception, invitation, knowledge, emotions, strategy and summary

Question 23

perception

Answer 23

elicit the pt’s perspective

Question 24

invitiation

Answer 24

ask the pt what they would like to know

Question 25

knowledge

Answer 25

provide info in small pieces - give an idicator first - speak in a tone that the news might be disappointing

Question 26

emotions

Answer 26

recognize and empathize w/ the pt’s emotions

Question 27

strategy and summary

Answer 27

set out a medical plan of action