Ownership of Reproductive Materials Policy

I. PURPOSE:

Ovation Fertility understands the importance of respecting personal choices with respect to reproductive materials. Given the importance around ownership of reproductive materials and how that ownership relates to the ability of individuals to make decisions with respect to disposition, use, and transfer of reproductive materials, Ovation Fertility believes that expectations and responsibilities of ownership should be addressed at the outset of fertility treatment. Ovation Fertility’s ownership policy reflects our desire for autonomy with respect to one’s own genetic material and the general principle that combined genetic material (i.e., embryos) should be jointly owned, absent a donation or other transfer. The policy described herein shall be the standard policy of Ovation Fertility and all ownership determinations will follow this policy unless a separate election is made. Due to the variety of circumstances and contingencies that could affect ownership, Ovation Fertility has made the decision not to accept outside agreements.

Record keeping in all aspects of IVF procedural practice must be thorough and complete. Specimen ownership and identification is imperative for proper record keeping and identification of reproductive materials throughout the entire IVF process. There must be traceability between initial ownership consents, the cryostorage consents, embryo data sheets, cryopreservation records, and cryostorage inventory. Due to the importance of indisputable evidence of ownership of reproductive materials, Ovation Fertility requires standardized determination and documentation of ownership of all reproductive materials, from initial encounter with the client(s) through final use, disposition, transfer, or disposal of reproductive materials.

II. POLICY:

Ovation Fertility has established a policy for ownership of all reproductive materials. Clients will be asked to acknowledge review and understanding of this policy and document the ownership of any and all reproductive material through the Ownership of Reproductive Materials Policy and Agreement form. This form will also require that the client(s) indicate their acceptance or non-acceptance of Ovation’s standard policy. As noted previously, Ovation Fertility cannot accept outside contracts or consents. All ownership instructions will be set forth on Ovation the Ownership of Reproductive Materials Policy and Agreement form as provided herein.

Ovation Fertility’s standard reproductive materials ownership policy is as follows:

GAMETE

Intended parent 1	Intended parent 2	Egg source	Owner of eggs	Sperm source	Owner of sperm
Female or	NIA	Any	IPl	Any	IPl
Male IPl
Female IPI	Male IP2	lPl	lPl	IP2	IP2
Female IPl	Male IP2	IPl	IPl	Anonymous	Joint
Female IPl	Male IP2	IPI	IPl	Known1	Joint
Female IPl	Male IP2	Anonymous	Joint	IP2	IP2
Female IPl	Male IP2	Known*	Joint	IP2	IP2
Female IPI	Male IP2	Known*	Joint	Known*	Joint
Female IPl	Male IP2	Anonymous	Joint	Known*	Joint
Female IPl	Male IP2	Known*	Joint	Anonymous	Joint
Female IPl	Male IP2	Anonymous	Joint	Anonymous	Joint
Female IPl	Female IP2	IPl	IPl	Anonymous	Joint
Female IPl	Female IP2	IPl	IPl	Known*	Joint
Female IPl	Female IP2	Known*	Joint	Anonymous	Joint
Female IPl	Female IP2	Known*	Joint	Known*	Joint
Female IPl	Female IP2	Anonymous	Joint	Known*	Joint

¹ In all cases with known donors, if the directed donation form is specific to only one person in the intended couple, then only that intended recipient will have ownership and the material will not be owned jointly. Indicated by*.

Female IPl	Female IP2	Anonymous	Joint	Anonymous	Joint
Male IPl	Male IP2	Anonymous	Joint	IP2	IP2
Male IPl	Male IP2	Known*	Joint	IP2	IP2
Male IPl	Male IP2	Known*	Joint	Known*	Joint
Male IPl	Male IP2	Known*	Joint	Anonymous	Joint
Male IPl	Male IP2	Anonymous	Joint	Known*	Joint
Male IPl	Male IP2	Anonymous	Joint	Anonymous	Joint

EMBRYO

Single	Client [intended parent] is the only owner
Couple	Client [intended parent] and partner as indicated on the Ovation Fertility consent will have equal joint ownership

Ovation Fertility laboratory staff performing cryopreservation of reproductive material(s) must refer to the client(s) Ownership of Reproductive Materials Policy and Agreement and the Reproductive Materials Cryopreservation & Storage Agreement to confirm and document proper ownership. Any discrepancies in ownership will be resolved immediately by contacting the client(s). Conflicting, ambiguous, or incomplete documents are not accepted, and new documents must be completed prior to any laboratory procedures. Any change in ownership of reproductive materials must be completed through the use of the Transfer of Reproductive Material Agreement form.

The name(s) and date of birth(s) listed as Client #1 and Client #2 (if a Client #2 is listed) must be transcribed exactly as they are written to the client(s) embryo / oocyte / semen data sheets, cryopreservation records, and cryostorage inventory. Individual labs may outline internal SOPs and labeling procedures that meet this requirement. Labeling of cryodevices must possess at least two unique identifiers, a specimen identifier, and date. The cryopreservation record must match the cryodevice labels, list an accurate description of cryodevice contents (as applicable), and identify cryopreservation protocol

III. SCOPE / PERSONNEL RESPONSIBILITIES

Ovation Fertility personnel will present a copy of the Ownership of Reproductive Materials Policy and Agreement to the client(s), explain the ownership of the applicable oocytes, sperm, and embryos under this policy and explain how ownership of the reproductive materials is used by Ovation Fertility with respect to use, transfer and disposition of reproductive materials. Once the clients have had an opportunity to have all their questions answered and express understanding of the policy, the client(s) will check the appropriate box indicating acceptance or non-acceptance of the standard ownership policy and sign the acknowledgement in the appropriate places. The executed Ownership of Reproductive Materials Policy and Agreement, and all executed storage agreement form(s), will be placed in the client(s) record. Ovation Fertility staff will explain the process for making changes to the stated ownership through the Transfer of Reproductive Materials Agreement form, should the client(s) change their minds in the future.

All Ovation Fertility laboratory personnel strictly adhere to the Media Preparation for ART Procedures policy when handling media and the Sterile Technique in the Laboratory policy in the handling, assessment, culturing, transfer, and cryopreservation of sperm, oocytes and embryos.

IV. REGULATORY REQUIREMENTS

1. RLM.11500 Cryopreservation
   1. RLM.11525 Specimen Handling
   1. RLM.11600 Specimen Labeling/Tracking
   1. RLM.12400 Specimen Storage/Long-Term Disposition

V. RELATED DOCUMENTS/FORMS/JOB AIDES

1. Ownership of Reproductive Materials Policy and Agreement
   1. Transfer of Reproductive Material Ownership form
   1. Reproductive Materials Cryopreservation & Storage Agreement
   1. Cryostorage Record
   1. Oocyte Data Sheet (if applicable)
   1. Embryo Data Sheet (if applicable)
   1. Semen Data Sheet (if applicable)

VI. DOCUMENT REVISION HISTORY

1. 01/23: New Policy: Corporate Policy establishing standardized reproductive materials ownership identification. – revision 1.0

VII. ANNUAL REVIEW BY LAB DIRECTOR

Review Date	Signature