HIV-discordant Couple Intrauterine Insemination

Status:

NO_LONGER_AVAILABLE

HIV-discordant Couple Intrauterine Insemination

Lead Sponsor:

University of Missouri-Columbia

Conditions:

Infertility

HIV Infections

Eligibility:

All Genders

18-38 years

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,...

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...

Eligibility Criteria

Inclusion

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.

Exclusion

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00975546

Last Update

December 2 2015

Active Locations (1)

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