HIV-discordant Couple Intrauterine Insemination

NCT00975546 | Unknown

• 1 other identifier: HIV-IUI
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose to treat couples who wish to have a child in which the man is HIV-positive and the woman is HIV-negative. The investigators call these couples HIV-discordant. On the average, an HIV-positive man, who does not participate in high-risk activities, will transmit HIV to a female partner one in every one thousand acts of intercourse without a condom. To reduce transmission of HIV, HIV-discordant couples are counseled to avoid intercourse altogether, or to use condoms during every act of intercourse. In order to have a child, these patients can use donor insemination. If they wish to have a natural child of the infected man, they can use a combination of medication of the man to reduce the amount of virus in his semen, and condom use except at the time of ovulation when the woman produces an egg. This reduces the chance of infecting the woman, but studies have shown that about 4% of women will be infected with HIV using this approach. Alternatively, they can use vitro fertilization (IVF) with intra cytoplasmic sperm injection (ICSI) in which eggs are collected from the woman after hormone-stimulation and are fertilized in the laboratory by injecting a single washed sperm from her husband into each egg. The resulting embryos can be transferred to the wife's uterus and/or frozen for later use. These procedures are believed to minimize the risk of HIV transmission (although the number of cases is low), but IVF-ICSI is very expensive and are not an option for everyone. A simpler method used for over 15 years in Europe is to collect the man's semen, wash the sperm in the laboratory, and test the sperm sample for HIV before placing it in the woman's uterus (intrauterine insemination; IUI). Although the risk of HIV transmission to the woman is presumably not zero with this method, over 4000 inseminations reported have not resulted in infection of any female patients or resulting children.

Conditions

Infertility; HIV Infections

Keywords

fertility; HIV discordant; HIV; Infertility in HIV-discordant couples; HIV seronegativity

Interventions

Sperm washing and testing for HIV contamination OTHER

Semen will undergo specialized washing to reduce viral contamination of sperm. The sperm are first separated from leukocytes and other seminal constituents by centrifugation over a stepwise gradient. Motile sperm will be separated from the resulting pellet by a swim-up step in which washed sperm are overlaid with fresh medium into which sperm migrate. The final sperm suspension will be stored while testing for HIV is performed by reverse transcription polymerase chain reaction (RT-PCR)

Intrauterine Insemination PROCEDURE

Intrauterine Insemination (IUI) will be performed on the HIV-negative wife, following standard clinical practice, using washed sperm from her HIV-positive husband after testing the IUI sample for HIV.

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: all
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

Missouri Center for Reproductive Medicine & Fertility

Columbia, Missouri, 65201, United States

Location

Related Publications (26)

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  PMID: 15482760 BACKGROUND

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• 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.

  PMID: 16753050 BACKGROUND

• 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.

  PMID: 11238138 BACKGROUND

• 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.

  PMID: 11425804 BACKGROUND

• 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.

  PMID: 11821074 BACKGROUND

• 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.

  PMID: 10397558 BACKGROUND

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• 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.

  PMID: 16756977 BACKGROUND

• 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.

  PMID: 9660417 BACKGROUND

• 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.

  PMID: 9121267 BACKGROUND

• 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.

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• 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.

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• 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.

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• 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.

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  PMID: 3122014 BACKGROUND

• 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.

  PMID: 2109169 BACKGROUND

• 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.

  PMID: 11718472 BACKGROUND

MeSH Terms

Conditions

Infertility; HIV Infections

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Danny J Schust, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

• Erma Z Drobnis, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: expanded access
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Asssistant Professor

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 11, 2009
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

US (1)