Immunomodulatory therapy to restore ovarian function and improve fertility in women with autoimmune premature ovarian insufficiency – a double-blind, placebo-controlled, randomized study

Autoimmune disorders are associated with increased risk of premature ovarian insufficiency (POI), leading to early menopause and infertility. The autoimmunity is thought to cause functional ovarian damage, that potentially can be reversed.

In fact, preliminary evidence from our proof-of-concept study with immunomodulatory therapy has shown successful results in harvesting mature eggs and even restoring menstrual cycles.To further explore these promising results, we aim to investigate the efficacy of immunomodulatory therapy with rituximab to restore ovarian function in autoimmune POI in a double-blind, placebo-controlled, randomized trial.

Primary outcome is egg retrieval after controlled ovarian hyperstimulation, and secondary outcomes are spontaneous menstrual bleeding, ovulation, changes in immune response and hormones, and quality of life during 12-month follow-up.POI is a devastating psychological and social blow to women seeking to bear their own children.

The disorder also has several negative health consequences including reduced quality of life, bone mineral density, cognition, and increased risk of cardiovascular disease.

Hormone replacement therapy effectively counteracts menopausal symptoms and many of the complications associated with POI, but the only fertility treatment that could be offered today is egg donation.

With immunomodulatory therapy, we hope to restore ovarian function and give these women the possibility to give birth to a biological child.