HIV-discordant Couple Intrauterine Insemination

Expanded access is no longer available for this treatment.

Sponsor:

Information provided by (Responsible Party):

Erma Drobnis, University of Missouri-Columbia

ClinicalTrials.gov Identifier:

NCT00975546

First received: September 10, 2009

Last updated: November 30, 2015

Last verified: November 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

September 10, 2009

Last Updated Date

November 30, 2015

Start Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Not Provided

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00975546 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

HIV-discordant Couple Intrauterine Insemination

Official Title ^ICMJE

Intrauterine Insemination for HIV-discordant Couples

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.

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 Type ^ICMJE

Expanded Access

Study Phase

Not Provided

Study Design ^ICMJE

Not Provided

Condition ^ICMJE

Infertility
HIV Infections

Intervention ^ICMJE

Other: Sperm washing and testing for HIV contamination
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)
Procedure: Intrauterine Insemination
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.

Study Arms

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

No longer available

Enrollment ^ICMJE

Not Provided

Completion Date

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 38 Years (Adult)

Accepts Healthy Volunteers

Not Provided

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00975546

Other Study ID Numbers ^ICMJE

HIV-IUI

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Erma Drobnis, University of Missouri-Columbia

Study Sponsor ^ICMJE

University of Missouri-Columbia

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Danny J Schust, MD	University of Missouri-Columbia
Principal Investigator:	Erma Z Drobnis, PhD	University of Missouri-Columbia

PRS Account

University of Missouri-Columbia

Verification Date

November 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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