Mononuclear-cell immunisation in prevention of recurrent miscarriages: a randomised trial

Area of Science:

• Reproductive Immunology
• Obstetrics and Gynecology

Background:

• Unexplained recurrent miscarriage may stem from alloimmune abnormalities hindering fetal survival.
• Paternal mononuclear cell immunization is a controversial treatment for alloimmune-mediated pregnancy loss.

Purpose of the Study:

• To investigate if paternal mononuclear cell immunization improves pregnancy success rates in couples with unexplained recurrent miscarriage.

Main Methods:

• A double-blind, randomized clinical trial involving 183 women with recurrent miscarriage.
• Participants were randomized to receive immunization with paternal mononuclear cells or sterile saline (control).
• Primary outcomes measured pregnancy failure (inability to conceive or termination before 28 weeks) versus success (gestation ≥ 28 weeks).

Main Results:

• In an intention-to-treat analysis, the success rate was 36% in the treatment group versus 48% in the control group (OR 0.60; p=0.108).
• Among pregnant women, success rates were 46% (treatment) and 65% (control) (OR 0.45; p=0.026).
• Results remained consistent after adjustments for maternal age and miscarriage history.

Conclusions:

• Immunization with paternal mononuclear cells does not enhance pregnancy outcomes in women experiencing unexplained recurrent miscarriage.
• This therapeutic approach is not advised for treating recurrent pregnancy loss.