Cap-Score™ prospectively predicts probability of pregnancy

Area of Science:

• Reproductive Medicine
• Andrology
• Sperm Biology

Background:

• Traditional semen analysis (SA) has limited predictive power for male fertility as it doesn't assess sperm's fertilizing capacity.
• Sperm capacitation, indicated by G_M1 localization (Cap-Score™), shows differences between fertile and infertile men, and in conception outcomes.
• Previous retrospective studies suggest Cap-Score's potential in predicting intrauterine insemination (IUI) success.

Purpose of the Study:

• To prospectively evaluate the Cap-Score's ability to predict male fertility.
• To determine if Cap-Score can predict clinical pregnancy within three IUI cycles.
• To compare the predictive value of Cap-Score against traditional SA and patient demographics.

Main Methods:

• Conducted a prospective study involving 208 men undergoing SA and Cap-Score analysis.
• Assessed Cap-Score and SA results against clinical pregnancy outcomes after up to 3 IUI cycles.
• Utilized logistic regression to evaluate Cap-Score and SA in predicting the probability of generating pregnancy (PGP).

Main Results:

• Men predicted to have a low Cap-Score had significantly lower absolute (10.6% vs. 29.5%) and cumulative (14.0% vs. 32.8% by cycle 3) pregnancy rates.
• Only Cap-Score, not age or SA parameters, significantly differed between men with and without pregnancy.
• Cap-Score was a significant predictor of PGP (p=0.01) in a logistic regression model, validated across multiple clinics with improved fit (p<0.001).

Conclusions:

• Cap-Score provides a practical and predictive assessment of male fertility.
• This method demonstrates significant utility in assisted reproduction and male infertility treatment.
• The Cap-Score model, using only Cap-Score as a predictor, offers a robust and accurate fertility assessment.