WHAT IS A DIRECTED DONOR?


A directed donor is a semen donor whose identity is known to the woman undergoing the assisted reproductive procedure - unlike an anonymous semen donor, whose identity is unknown - but who is not her sexually intimate partner.

According to regulations set forth by the New York State Department of Health (NYSDOH) and the Food and Drug Administration (FDA), directed semen donors must be screened and tested in order to (a) provide a reasonable chance for conception, (b) provide no increased risk of fetal abnormality, and (c) provide a reduced risk of pathogen (disease) transmission. As such, PAF's Directed Donor Program is designed to assist physicians and their patients with all aspects of directed donor screening and testing in compliance with regulations.

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Who are the participants in a
Directed Donor Program?

Specifically, the parties participating in a directed donor contract are as follows:

"Owner"
The Owner is the person who wishes to parent a child(ren) resulting from semen donated by the Directed Donor.   The Owner may be the Directed Donor, the Recipient, or other third party.   The Owner is usually responsible for all charges incurred.

 "Partner"  (May or may not be applicable.)
The Partner is the Owner's spouse, domestic partner, or other significant person, who wishes to parent a child(ren) resulting from semen donated by the Directed Donor.   The Partner may also be the Recipient.

"Directed Donor"
The Directed Donor is the male who is donating his semen and who directs his specimens to be used as per the instructions of the Owner.   The Directed Donor is known to the recipient, but he is not her sexually intimate partner.   The Directed Donor may also be the Owner.   If the Directed Donor is not the Owner, he relinquishes all rights to the specimens and any children that may result.

"Recipient"
The Recipient is the female that will undergo an assisted reproductive procedure using the cryopreserved semen donated by the Directed Donor for the purpose of pregnancy.   The Recipient may also be the Owner.

Some examples of directed donor situations are as follows:

- A male friend (Directed Donor) donating semen to a female friend (Owner/Recipient) for the purpose of pregnancy.

- A brother (Directed Donor) donating semen to his infertile brother (Owner) for the purpose of impregnating his spouse (Recipient/Partner).

- A male (Owner/Directed Donor) who wishes his semen be used for the purpose of impregnating a surrogate (Recipient)*.

* The situation whereby the Owner is also the Directed Donor constitutes a surrogate parenting scenario, which is legally complicated.   In 1992, New York's State legislature declared surrogate parenting contracts void, unenforceable and contrary to public policy.   Parties to uncompensated surrogacy contracts cannot have their contracts enforced by New York courts if a dispute arises.   Parties to surrogate parenting contracts involving compensation are subject to civil, and even criminal penalties.

Whatever the situation, using semen of a known donor brings with it certain inherent difficulties and as such, all participants engaging in PAF's Directed Donor Program are strongly advised to seek legal counsel of their choosing.

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What is the procedure for participating
in the Directed Donor Program?

The following outlines the procedure for participating in the Directed Donor Program:

1. Directed Donor Application Filled Out by Directed Donor Applicant

It is recommended that the application be completed and submitted to PAF prior to the first appointment. Acceptance of the directed donor into the Directed Donor Program is based in part on review of the application by PAF's Medical Director and the recipient's attending physician.

2. First Directed Donor Appointment at PAF - Interview and Semen Analysis

At the time of this appointment, the application is reviewed with the directed donor and a semen specimen is produced for analysis, processing (both Standard and Pre-Washed), freezing and cryosurvival rating.   The directed donor will be given the PAF Physical Examination Form which must be completed prior to the second directed donor appointment either by the donor's personal physician or by PAF's consulting physician.

The first specimen is used to assess the quality of the directed donor's semen specimen and its ability to withstand the freezing process and is not stored at this time.   This is done so as to avoid the expense of blood/urine testing and storage fees for a directed donor whose semen analysis yields unfavorable results.

3. Semen Analysis Report Sent to the Recipient's Referring Physician

The directed donor's semen analysis and cryosurvival results are sent to the recipient's physician for assessment and written approval of the directed donor. The physician will also inform PAF as to the preferred method of processing (Standard or Pre-Washed).  

If the owner / recipient is not currently working with a physician, the specimen will be processed by which ever method the Owner prefers.   However, written approval of the directed donor must ultimately be obtained from the recipient's physician prior to specimen release.

4. Second Directed Donor Appointment - Semen Storage and Blood/Urine Tests

PAF Physical Examination Form must be completed and returned to PAF at this appointment.

The directed donor will produce a semen specimen for analysis, cryopreservation and storage, and will produce a urine specimen and have his blood drawn for the required testing.   All Directed Donors are -

- tested for HIV I/II (AIDS)
- tested for Hepatitis B - tested for Hepatitis C
- tested for HTLV-I/II-
- tested for syphilis
- tested for gonorrhea
- tested for chlamydia
- screened for Cystic Fibrosis, thereby reducing the risk of being a CF carrier to less than 1%.
- screened for carrier status if they belong to a population at high risk for Tay Sachs, Canavan's, Gaucher's, Sickle Cell Anemia or Thalassemia

Continuation in the program is based on the results of the tests and the physical examination.   If all parameters of testing are acceptable, the specimen will remain in quarantine for a minimum of 6 months until the directed donor's blood is retested for specimen release.

In addition, the Owner, Owner's Partner, Directed Donor, and Recipient must sign the Directed Donor Program Informed Consent and Agreement.

5. Additional Directed Donor Appointments
Additional specimens may be stored as recommended by the referring physician.

6. Final Blood Tests Six (6) Months After Last Specimen Deposit
The directed donor's blood is retested as required in order to release the specimens from quarantine. This testing is subject to specific time restrictions and can only be performed by laboratories which are licensed by the NYSDOH.

7. Release and Delivery of Semen Deposits
If all parameters of the retesting are acceptable, the Directed Donors specimens may be released from quarantine for use. To release specimens, a notarized Request for Release of Specimens form must be submitted to PAF prior to the actual delivery of the specimens. Specimens can be delivered only to a licensed physician.

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Why are specimens quarantined for six months
and is the quarantine period mandatory?


The directed donor's specimens are maintained in quarantine in order to prevent the transmission of a number of sexually transmitted diseases, amongst them AIDS. The directed donor's blood is tested for HIV-AIDS at the time he stores his first specimen. However, antibodies to the AIDS virus may not be detectable in blood until six to eight weeks after infection. Thus, it is possible for the directed donor's specimen to carry the AIDS virus even after initially testing 'Negative' for the AIDS antibody. To ensure this does not occur, the directed donor's semen is maintained in quarantine for a minimum of six months (180 days) after which the directed donor's blood is retested for the AIDS antibody. If the blood retests 'Negative,' the specimen is considered to be free of the AIDS virus and may be released for use.

Both the New York State Department of Health and FDA regulations require the testing and quarantine of anonymous and directed donors. Although regulatory agencies permit clients to waive the quarantine period of directed donors in writing, Park Avenue Fertility does not allow for this, and as such, the minimum six month specimen quarantine is mandatory for all directed donors in PAF's Directed Donor Program. Consequently, if the directed donor is unable to be retested after the required quarantine period, the specimens in storage will not be able to be released.

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How do I obtain a Directed Donor application
and set up an appointment?

To obtain a directed donor application or to schedule your first Directed Donor appointment please call PAF.

If you have any questions or concerns about PAF's Directed Donor Program please call the laboratory.

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What fees are involved in the Directed Donor Program?


All fees are payable in full before or on the date of delivery. PAF does not accept insurance as payment for services rendered, but will furnish you with an itemized receipt.

Initial Specimen Processing - no storage $ 375.00
Semen Analysis w/ Strict Morphology - Standard and Pre-wash Processing Cryopreservation - Post Thaw Analyses
Consecutive Specimens Processing - Storage
Standard Processing
$175.00 per specimen
Pre-Wash Processing
$250.00 per specimen
Cryopreservation
$75.00 per specimen
Six Months Storage
$290.00
Required Testing
STD Blood Panel
$300.00
STD Blood Panel - Quarantine Release
$300.00
Chlamydia & Gonorrhea PCR
$150.00
Cystic Fibrosis
$125.00
Physical Examination 1
 $150.00
CMV Culture 2
 $150.00
Tay Sachs Carrier 3
 $150.00
Sickle Cell Carrier 3
 $75.00
Thalassemia 3
 $75.00

1 Physical Exam may be performed by any licensed physician. Please request PAF Physical Exam Form for your doctor's use.
2 Performed only if CMV anitbody test (part of STD Blood Panel) result is 'Positive.'
3 Based on Racial / Ethnic Bacground


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