- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00975546
HIV-discordant Couple Intrauterine Insemination
Intrauterine Insemination for HIV-discordant Couples
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Contacts and Locations
Study Locations
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Missouri
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Columbia, Missouri, United States, 65201
- Missouri Center for Reproductive Medicine & Fertility
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Couple must:
- attest to safe sex practices
- know the HIV-status of their partner
- be informed of risks of this procedure and alternatives, including donor insemination
- have the ability to provide informed consent
- been referred or self-refer to Dr. Schust for infertility treatment
Female must:
- be 18-38 years of age
- have a normal menstrual cycle before the IUI cycle
- be negative for HIV, gonorrhea, chlamydia, syphilis, hepatitis B and hepatitis C
- have a standard infertility evaluation and be a candidate for intrauterine insemination
Male must:
- be at least 18 years of age
- be HIV-seropositive
- be under the care of an infectious disease specialist
- disease must be under control without evidence of acquired immunodeficiency syndrome (AIDS), with viral load <50,000 copies/mL and CD4 count > 250 cells/mL for the preceding 6 month period
- have semen quality adequate for intrauterine insemination
If the couple does not achieve pregnancy after IUI, they may continue in the study for 5 additional treatment subsequent cycles. The man must continue to receive care for his HIV and the disease must continue to be under control. Before each cycle of insemination, the couple must each sign an attestation statement that he/she is following safe sex practices, and have repeat testing for sexually-transmitted infections.
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Danny J Schust, MD, University of Missouri-Columbia
- Principal Investigator: Erma Z Drobnis, PhD, University of Missouri-Columbia
Publications and helpful links
General Publications
- Bujan L, Pasquier C, Labeyrie E, Lanusse-Crousse P, Morucci M, Daudin M. Insemination with isolated and virologically tested spermatozoa is a safe way for human immunodeficiency type 1 virus-serodiscordant couples with an infected male partner to have a child. Fertil Steril. 2004 Oct;82(4):857-62. doi: 10.1016/j.fertnstert.2004.02.128.
- Bujan L, Hollander L, Coudert M, Gilling-Smith C, Vucetich A, Guibert J, Vernazza P, Ohl J, Weigel M, Englert Y, Semprini AE; CREAThE network. Safety and efficacy of sperm washing in HIV-1-serodiscordant couples where the male is infected: results from the European CREAThE network. AIDS. 2007 Sep 12;21(14):1909-14. doi: 10.1097/QAD.0b013e3282703879.
- Chen JL, Philips KA, Kanouse DE, Collins RL, Miu A. Fertility desires and intentions of HIV-positive men and women. Fam Plann Perspect. 2001 Jul-Aug;33(4):144-52, 165.
- Gilling-Smith C, Nicopoullos JD, Semprini AE, Frodsham LC. HIV and reproductive care--a review of current practice. BJOG. 2006 Aug;113(8):869-78. doi: 10.1111/j.1471-0528.2006.00960.x. Epub 2006 Jun 2.
- Gilling-Smith C, Smith JR, Semprini AE. HIV and infertility: time to treat. There's no justification for denying treatment to parents who are HIV positive. BMJ. 2001 Mar 10;322(7286):566-7. doi: 10.1136/bmj.322.7286.566. No abstract available.
- Englert Y, Van Vooren JP, Place I, Liesnard C, Laruelle C, Delbaere A. ART in HIV-infected couples: has the time come for a change of attitude? Hum Reprod. 2001 Jul;16(7):1309-15. doi: 10.1093/humrep/16.7.1309.
- Ethics Committee of the American Society for Reproductive Medicine. Human immunodeficiency virus and infertility treatment. Fertil Steril. 2002 Feb;77(2):218-22. doi: 10.1016/s0015-0282(01)03000-x. No abstract available.
- Kim LU, Johnson MR, Barton S, Nelson MR, Sontag G, Smith JR, Gotch FM, Gilmour JW. Evaluation of sperm washing as a potential method of reducing HIV transmission in HIV-discordant couples wishing to have children. AIDS. 1999 Apr 16;13(6):645-51. doi: 10.1097/00002030-199904160-00004.
- Leruez-Ville M, de Almeida M, Tachet A, Dulioust E, Guibert J, Mandelbrot L, Salmon D, Jouannet P, Rouzioux C. Assisted reproduction in HIV-1-serodifferent couples: the need for viral validation of processed semen. AIDS. 2002 Nov 22;16(17):2267-73. doi: 10.1097/00002030-200211220-00006.
- Lesage B, Vannin AS, Emiliani S, Debaisieux L, Englert Y, Liesnard C. Development and evaluation of a qualitative reverse-transcriptase nested polymerase chain reaction protocol for same-day viral validation of human immunodeficiency virus type 1 ribonucleic acid in processed semen. Fertil Steril. 2006 Jul;86(1):121-8. doi: 10.1016/j.fertnstert.2005.12.021. Epub 2006 Jun 6.
- Marina S, Marina F, Alcolea R, Exposito R, Huguet J, Nadal J, Verges A. Human immunodeficiency virus type 1--serodiscordant couples can bear healthy children after undergoing intrauterine insemination. Fertil Steril. 1998 Jul;70(1):35-9. doi: 10.1016/s0015-0282(98)00102-2.
- Mandelbrot L, Heard I, Henrion-Geant E, Henrion R. Natural conception in HIV-negative women with HIV-infected partners. Lancet. 1997 Mar 22;349(9055):850-1. doi: 10.1016/S0140-6736(05)61754-0. No abstract available.
- Pasquier C, Anderson D, Andreutti-Zaugg C, Baume-Berkenbosch R, Damond F, Devaux A, Englert Y, Galimand J, Gilling-Smith C, Guist'hau O, Hollander L, Leruez-Ville M, Lesage B, Maillard A, Marcelin AG, Schmitt MP, Semprini A, Vourliotis M, Xu C, Bujan L; CREAThE Network. Multicenter quality control of the detection of HIV-1 genome in semen before medically assisted procreation. J Med Virol. 2006 Jul;78(7):877-82. doi: 10.1002/jmv.20636.
- Politch JA, Mayer KH, Anderson DJ. Depletion of CD4+ T cells in semen during HIV infection and their restoration following antiretroviral therapy. J Acquir Immune Defic Syndr. 2009 Mar 1;50(3):283-9. doi: 10.1097/QAI.0b013e3181989870.
- Politch JA, Xu C, Tucker L, Anderson DJ. Separation of human immunodeficiency virus type 1 from motile sperm by the double tube gradient method versus other methods. Fertil Steril. 2004 Feb;81(2):440-7. doi: 10.1016/j.fertnstert.2003.06.028.
- Quayle AJ, Xu C, Tucker L, Anderson DJ. The case against an association between HIV-1 and sperm: molecular evidence. J Reprod Immunol. 1998 Dec;41(1-2):127-36. doi: 10.1016/s0165-0378(98)00053-9.
- Quayle AJ, Xu C, Mayer KH, Anderson DJ. T lymphocytes and macrophages, but not motile spermatozoa, are a significant source of human immunodeficiency virus in semen. J Infect Dis. 1997 Oct;176(4):960-8. doi: 10.1086/516541.
- Sauer MV. Sperm washing techniques address the fertility needs of HIV-seropositive men: a clinical review. Reprod Biomed Online. 2005 Jan;10(1):135-40. doi: 10.1016/s1472-6483(10)60815-2.
- Semprini AE, Levi-Setti P, Bozzo M, Ravizza M, Taglioretti A, Sulpizio P, Albani E, Oneta M, Pardi G. Insemination of HIV-negative women with processed semen of HIV-positive partners. Lancet. 1992 Nov 28;340(8831):1317-9. doi: 10.1016/0140-6736(92)92495-2.
- Semprini AE, Bujan L, Englert Y, Smith CG, Guibert J, Hollander L, Ohl J, Vernazza P. Establishing the safety profile of sperm washing followed by ART for the treatment of HIV discordant couples wishing to conceive. Hum Reprod. 2007 Oct;22(10):2793-4; author reply 2794-5. doi: 10.1093/humrep/dem197. Epub 2007 Jul 3. No abstract available.
- Smith JR, Forster GE, Kitchen VS, Hooi YS, Munday PE, Paintin DB. Infertility management in HIV positive couples: a dilemma. BMJ. 1991 Jun 15;302(6790):1447-50. doi: 10.1136/bmj.302.6790.1447. No abstract available.
- Sunderam S, Hollander L, Macaluso M, Vucetich A, Jamieson DJ, Osimo F, Duerr A, Semprini AE. Safe conception for HIV discordant couples through sperm-washing: experience and perceptions of patients in Milan, Italy. Reprod Health Matters. 2008 May;16(31):211-9. doi: 10.1016/S0968-8080(08)31342-1.
- Vernazza PL, Gilliam BL, Dyer J, Fiscus SA, Eron JJ, Frank AC, Cohen MS. Quantification of HIV in semen: correlation with antiviral treatment and immune status. AIDS. 1997 Jul;11(8):987-93.
- Centers for Disease Control (CDC). Semen banking, organ and tissue transplantation, and HIV antibody testing. MMWR Morb Mortal Wkly Rep. 1988 Feb 5;37(4):57-8, 63. No abstract available.
- Centers for Disease Control (CDC). HIV-1 infection and artificial insemination with processed semen. MMWR Morb Mortal Wkly Rep. 1990 Apr 20;39(15):249, 255-6. No abstract available.
- Centers for Disease Control and Prevention. Revised guidelines for HIV counseling, testing, and referral. MMWR Recomm Rep. 2001 Nov 9;50(RR-19):1-57; quiz CE1-19a1-CE6-19a1.
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIV-IUI
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