This clinical trial studies the effectiveness of a vaginal gel called PKB171 containing pentoxifylline for couples dealing with mild male factor infertility. Male factor infertility occurs when there are issues with sperm quality, specifically conditions known as oligospermia (low sperm count) and asthenozoospermia (poor sperm movement). The purpose is to determine if using this gel after intercourse can help achieve pregnancy in couples who have been unable to conceive.
The study compares two treatments: the PKB171 gel and a placebo gel. Neither the couples nor their doctors will know which gel is being used. The gel is applied vaginally after sexual intercourse, and couples can participate in the treatment for up to three months. During this time, doctors will monitor whether pregnancy occurs and check for any side effects from using the gel.
The main goal is to see if the gel helps achieve clinical pregnancy, which means a pregnancy where the baby’s heartbeat can be detected by ultrasound examination between 6 to 8 weeks of pregnancy. The study will also look at other important factors such as the overall pregnancy rate, pregnancy complications, and the safety of using the gel.



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