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MP 4.02.02 Paternal or Fetal Antigen Immunotherapy for Recurrent Fetal Loss


Medical Policy    
Original Policy Date
Last Review Status/Date
Reviewed with literature search/1:2004
  Return to Medical Policy Index


Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.




This procedure involves the artificial stimulation of the protective maternal immune response using biological preparations containing paternal or fetal antigens to help prevent spontaneous abortion when no detectable cause can be identified. Three techniques are used: seminal plasma, trophoblast membranes, and paternal leukocytes. Paternal leukocytes have been used most commonly.

  • Seminal Plasma:

Seminal plasmas and blood specimens from normal donors are capsulated and administered as vaginal suppositories on days 7, 14, and 21 of the monthly cycle and continued twice weekly after the first missed menses until 30 weeks into pregnancy.

  • Trophoblast Membrane:

Extracts are prepared from placentas collected at delivery from healthy term pregnancies. Villous tissue is separated from other placental components. The sieved solution is centrifuged. Membrane pellets are resuspended in sterile, pyrogen-free saline, then UV-irradiated, washed, re-homogenized, and lyophilized for storage. Membrane pellets are then reconstituted and administered with saline.

  • Paternal Leukocytes:

Paternal whole blood is subjected to density gradient centrifugation. Mononuclear leukocytes are removed from the gradient, washed, and resuspended in normal saline. Patients are immunized with the paternal leukocytes and then encouraged to conceive within a short time frame.




Paternal and fetal antigen immunotherapy using seminal plasma, trophoblast membrane, or paternal leukocyte applications to prevent recurrent fetal loss is considered investigational.



Policy Guidelines

Recurrent spontaneous abortion (RSA) is defined as 3 or more consecutive pregnancies with the same sexual partner, each ending in miscarriage prior to 20 weeks’ gestation. RSA may be caused by genetic, anatomic, endocrinologic, or autoimmune abnormalities.



Benefit Application

BlueCard/National Account Issues

Couples who experience recurrent fetal loss are technically not infertile, since pregnancy is initiated. Therefore, plans may wish to consider whether any benefits/contracts exclusions or limitations for infertility may apply to treatment of recurrent spontaneous abortion.




2002-3 Update
This policy was originally based on a 1995 TEC Assessment (1) that concluded that paternal or fetal antigen immunotherapy did not meet the TEC criteria as a treatment of recurrent spontaneous abortion. A search of literature was completed through the MEDLINE database for the period of 1995 through November 2003. The search did not identify any randomized controlled trials published during this period. Therefore the policy statement is unchanged. In general, research interest in immunotherapy as a treatment of recurrent spontaneous abortion has focused on the use of intravenous immunoglobulin. This therapy is considered separately in policy No. 8.01.05.


  1. TEC Assessments 1995: Tab 18






No Code 

ICD-9 Procedure 


(Seminal plasma) suppository insertion 



(Trophoblast membrane) injection or other therapeutic or prophylactic substance 

ICD-9 Diagnosis 


Habitual aborter 


No Code 

Type of Service 


Place of Service 

Outpatient, Physician’s Office 




Fetal and Paternal Antigen Immunotherapy for Recurrent Fetal Loss
Fetal Loss, Recurrent
Immunotherapy for Fetal Loss
Paternal or Fetal Antigen Immunotherapy for Recurrent Fetal Loss
Recurrent Fetal Loss



Policy History

Date Action Reason
3/31/96 Add policy to OB/GYN/Repro section New policy
10/08/02 Replace policy Policy updated; policy statement unchanged
02/25/04 Replace policy Policy updated with literature search; no change in policy statement


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