InfertilityNCT00975546
HIV-discordant Couple Intrauterine Insemination
A study testing Sperm washing and testing for HIV contamination and Intrauterine Insemination in people with Infertility and HIV Infections, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 38 years
- Conditions the study is for
- Infertility, HIV Infections
- What is being tested?
- Sperm washing and testing for HIV contamination and Intrauterine Insemination
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- All sexes
- Adult
Who may be able to join
- 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
Show all 18Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Missouri Center for Reproductive Medicine & Fertility
Columbia, Missouri, 65201
About this study
Official title: Intrauterine Insemination for HIV-discordant Couples
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.
Read the detailed description
This study will enroll couples who wish to have a child in which the man is HIV-seropositive and the woman is HIV-seronegative. The couple will be counseled about their reproductive options, including in vitro fertilization (IVF) donor insemination and adoption. The male patient will be using appropriate therapy to reduce the virus in his semen. 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). Specimens found negative for HIV will then be used for IUI (review: Gilling-Smith et al, 2006; Bujan et al 2007). There is presumably some risk of HIV transmission to the woman and resulting child with this approach; however, over 4000 inseminations reported in Europe over the last 15 years have not resulted in infection of any female patient or resulting child. The woman will be followed for a year after the final IUI to assess seroconversion. If a child is born, he or she will be tested for HIV at 3 months of age.
- Conditions
- Infertility, HIV Infections
- Being tested
- Sperm washing and testing for HIV contamination, Intrauterine Insemination
- Keywords
- fertility, HIV discordant, HIV, Infertility in HIV-discordant couples, HIV seronegativity
- Medical subject headings
- Infertility, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sperm washing and testing for HIV contaminationOther
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 InseminationProcedure or surgery
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erma Drobnis, University of Missouri-Columbia
- Investigators
- Danny J Schust, MD, Principal investigator, University of Missouri-ColumbiaErma Z Drobnis, PhD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975546
- Sponsor's protocol ID
- HIV-IUI
- Status last verified
- Nov 2015
- First submitted
- 10 Sep 2009
- Last updated
- 2 Dec 2015
- Results posted
- No
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.
PubMed 15482760Bujan 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.
PubMed 17721098Chen 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.
PubMed 11496931Gilling-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.
PubMed 16753050Gilling-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.
PubMed 11238138Englert 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.
PubMed 11425804Ethics 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.
PubMed 11821074Kim 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.
PubMed 10397558Leruez-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.
PubMed 12441798Lesage 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.
PubMed 16756977Marina 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.
PubMed 9660417Mandelbrot 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.
PubMed 9121267Pasquier 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.
PubMed 16721844Politch 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.
PubMed 19194315Politch 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.
PubMed 14967387
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrauterine Insemination for HIV-discordant Couples
- ClinicalTrials.gov ID
- NCT00975546
- Acronym / sponsor ID
- HIV-IUI
- Conditions
- Infertility, HIV Infections
- Keywords
- fertility, HIV discordant, HIV, Infertility in HIV-discordant couples, HIV seronegativity
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- First posted
- 11 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will enroll couples who wish to have a child in which the man is HIV-seropositive and the woman is HIV-seronegative. The couple will be counseled about their reproductive options, including in vitro fertilization (IVF) donor insemination and adoption. The male patient will be using appropriate therapy to reduce the virus in his semen. 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). Specimens found negative for HIV will then be used for IUI (review: Gilling-Smith et al, 2006; Bujan et al 2007). There is presumably some risk of HIV transmission to the woman and resulting child with this approach; however, over 4000 inseminations reported in Europe over the last 15 years have not resulted in infection of any female patient or resulting child. The woman will be followed for a year after the final IUI to assess seroconversion. If a child is born, he or she will be tested for HIV at 3 months of age.
Study design
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sperm washing and testing for HIV contaminationSemen 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) | Other | – |
| Intrauterine InseminationIntrauterine 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. | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Background: PubMed 15482760Bujan 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.
- Background: PubMed 17721098Bujan 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.
- Background: PubMed 11496931Chen 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.
- Background: PubMed 16753050Gilling-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.
- Background: PubMed 11238138Gilling-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.
- Background: PubMed 11425804Englert 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.
- Background: PubMed 11821074Ethics 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.
- Background: PubMed 10397558Kim 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.
- Background: PubMed 12441798Leruez-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.
- Background: PubMed 16756977Lesage 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.
- Background: PubMed 9660417Marina 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.
- Background: PubMed 9121267Mandelbrot 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danny J Schust, MD principal investigator
University of Missouri-Columbia
Erma Z Drobnis, PhD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sperm washing and testing for HIV contamination and Intrauterine Insemination in people with Infertility and HIV Infections, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00975546, which also lists 26 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2015.