Intrauterine Insemination In HIV-Discordant Couples (ARTEMIS)
19. února 2016 aktualizováno: Boston Medical Center
This study aims to assess the feasibility of a novel standard of care technique for intrauterine insemination (IUI) in HIV-discordant couples in the United States.
This study will involve couples in which the male partner is HIV positive, but the female partner is negative.
The investigators will institute a protocol similar to those used presently throughout Europe with good success.
To date, no HIV seroconversions have occurred in over 4000 inseminations performed in HIV serodiscordant couples.
All male subjects will be on stable HAART, and have undetectable serum viral loads prior to insemination.
Semen samples will be subjected to a stringent sperm wash procedure and screened for HIV RNA.
Female subjects will be followed post-insemination for seroconversion and pregnancy.
Infants will be followed for seroconversion at birth through 4 months of age.
Přehled studie
Postavení
Ukončeno
Podmínky
Intervence / Léčba
Detailní popis
This study aims to assess the feasibility of a novel standard of care technique for intrauterine insemination (IUI) in HIV-discordant couples in the United States. This study will involve couples in which the male partner is HIV positive, but the female partner is negative.
The investigators will institute a protocol similar to those used presently throughout Europe with good success. To date, no HIV seroconversions have occurred in over 4000 inseminations performed in HIV serodiscordant couples.
All male subjects will be on stable HAART and have undetectable serum viral loads prior to insemination. For semen samples, seminal fluid will be separated from sperm using a density gradient/swim-up separation technique. The purified sperm sample will be washed, and screened for HIV RNA using sensitive real-time RT-PCR. Samples with detectable traces of HIV RNA will not be used for insemination. Samples with no detectable traces of HIV RNA will be used for a standard intrauterine insemination of the female partner.
Female subjects will be followed post-insemination for seroconversion and pregnancy. Infants will be followed for seroconversion at birth through 3 months of age.
The data being collected in this pilot feasibility study will be mostly descriptive, lacking sample size to achieve statistical power for testing. However, the investigators will use case-control analysis to compare couples who achieve pregnancy with those who do not across demographics and markers of HIV disease progression. Additionally, the investigators have developed a 14 item, 5-point Likert scale to assesses the psychosocial impact of reproductive health issues stemming from HIV-discordance in both the female and male participants.
The expected duration for any unique subject couple is 3 to 12 months, depending on pregnancy. It is expected that the interventional portion of this study will continue for up to 2 years, depending on pregnancies.
Typ studie
Intervenční
Zápis (Aktuální)
10
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02118
- Boston Medical Center
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 50 let (Dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- Couples with HIV discordance with an HIV seronegative female partner and HIV seropositive male partner
- Men must be HIV positive with an undetectable viral load (<75 copies/ml)
- Men must be clinical stable on antiretroviral therapy for 6 months
- Men must have a CD4 count > 250 at screening
- Men must be between 18-50 years of age
- Men must have a baseline test sperm preparation demonstrating at least 10 million motile sperm per sample
- Men must have a letter of medical clearance specific for this procedure from primary care physician stating that subject is in good health and psychologically stable
- Men must be willing to have constituent follow-up of HIV care throughout study participation
- Women must have an HIV-1/HIV-2 negative serology at screening
- Women must be between 18-40 years of age
- Women must have a body mass index (BMI) less than 30
- Women must be a non-smoker
- Women must be ovulatory (as determined by LH tracking)
- Women must have normal uterine cavity with at least one documented patent fallopian tube (as determined by hysterosalpingogram)
- Women must have adequate day 3 ovarian reserves: FSH,12 mlU/ml and estradiol<80pg/ml
- Women must have no evidence of active urogenital infection at screening
- Women must have a normal PAP smear and GC/Chlamydia at screening
- Women must have a letter of medical clearance specific to this procedure from subject's primary care physician stating that subject is in good health and psychological stable.
Exclusion Criteria:
- Subjects with untreated sexually transmitted diseases (syphilis, GC, CT)
- Men with detectable viral load (>75) at screening
- Subjects with any condition (including, but not limited to alcohol and drug use), which, in the opinion of the investigator, could compromise the subject's safety or adherence to the protocol
- Subjects with any uncontrollable medical or psychiatric condition that,in the opinion of the investigator, cannot be adequately stabilized and could be considered a contraindication to participation
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Pregnancy
Časové okno: Sixteen days after IUI
|
A serum pregnancy test will be performed 16 days after IUI if menses is missed.
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Sixteen days after IUI
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Post-IUI HIV Infection of Female Subject
Časové okno: Four weeks after IUI
|
The female subject will be tested for HIV by branch-DNA (b-DNA) test four weeks after each insemination.
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Four weeks after IUI
|
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Female Subject HIV-1/HIV-2 Serology
Časové okno: Three, six, nine (pregnant only) and twelve months after insemination
|
If the female subject does not become pregnant, she will be tested for HIV-1/HIV-2 serology at 3 months, 6 months and 12 months after the insemination.
If repeat inseminations are performed, the above-stated timeline will be followed based on the last insemination performed.
If the female subject does become pregnant, she will be tested for HIV-1/HIV-2 serology at 3 months, 6 months and 9 months after the insemination, and again at 3 months postpartum.
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Three, six, nine (pregnant only) and twelve months after insemination
|
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Infant HIV-1/HIV-2 Serology
Časové okno: Three months of age
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For a successful birth, the infant will undergo an HIV-1/HIV-2 serology test at three months of age.
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Three months of age
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Margaret M Sullivan, MD, Boston Medical Center
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
- 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.
- 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.
- Anderson DJ, Politch JA. Providing fertility care to HIV-1 serodiscordant couples: a biologist's point of view. Am J Bioeth. 2003 Winter;3(1):47-9. doi: 10.1162/152651603321611980. No abstract available.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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, 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.
- Sauer MV, Wang JG, Douglas NC, Nakhuda GS, Vardhana P, Jovanovic V, Guarnaccia MM. Providing fertility care to men seropositive for human immunodeficiency virus: reviewing 10 years of experience and 420 consecutive cycles of in vitro fertilization and intracytoplasmic sperm injection. Fertil Steril. 2009 Jun;91(6):2455-60. doi: 10.1016/j.fertnstert.2008.04.013. Epub 2008 Jun 13.
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. září 2009
Primární dokončení (Aktuální)
1. září 2012
Dokončení studie (Aktuální)
1. října 2013
Termíny zápisu do studia
První předloženo
28. července 2010
První předloženo, které splnilo kritéria kontroly kvality
30. července 2010
První zveřejněno (Odhad)
2. srpna 2010
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
22. února 2016
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
19. února 2016
Naposledy ověřeno
1. ledna 2012
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ARTEMIS
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