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

Conditions

Autoimmune Premature Ovarian Insufficiency

Brief summary

Egg retrieval (yes/no) in response to controlled ovarian hyperstimulation at 4 to 6 months post-rituximab treatment compared to placebo, as well as within the rituximab-treated group at 4 to 6 and 12 months after the last treatment session compared to baseline.

Detailed description

Occurrence of spontaneous menstrual bleeding (yes/no) at any point during the 19-month study period., Proportion of participants who achieve ovulation (defined as serum progesterone >10 nmol/L) at any time during the study period., Changes in B-cell count, auto-antibody indices, and immunoglobulin (IgG) levels from baseline to the end of the study period., Changes in serum follicle-stimulating hormone (FSH) and anti-Müllerian hormone (AMH) levels from baseline to the end of the study period., Changes in quality of life scores, as measured by validated instruments (AddiQol, PGWB, SF-36, and MRS), from baseline to the end of the study period., Safety endpoint: the incidence and severity of adverse events, hospital admissions, infections, allergic reactions and over stimulation in relation to the controlled ovarian hyperstimulation.

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Interventions

DRUGRITUXIMAB

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Egg retrieval (yes/no) in response to controlled ovarian hyperstimulation at 4 to 6 months post-rituximab treatment compared to placebo, as well as within the rituximab-treated group at 4 to 6 and 12 months after the last treatment session compared to baseline.	—

Secondary

Measure	Time frame
Occurrence of spontaneous menstrual bleeding (yes/no) at any point during the 19-month study period., Proportion of participants who achieve ovulation (defined as serum progesterone >10 nmol/L) at any time during the study period., Changes in B-cell count, auto-antibody indices, and immunoglobulin (IgG) levels from baseline to the end of the study period., Changes in serum follicle-stimulating hormone (FSH) and anti-Müllerian hormone (AMH) levels from baseline to the end of the study period., Changes in quality of life scores, as measured by validated instruments (AddiQol, PGWB, SF-36, and MRS), from baseline to the end of the study period., Safety endpoint: the incidence and severity of adverse events, hospital admissions, infections, allergic reactions and over stimulation in relation to the controlled ovarian hyperstimulation.	—

Measure

Time frame

Occurrence of spontaneous menstrual bleeding (yes/no) at any point during the 19-month study period., Proportion of participants who achieve ovulation (defined as serum progesterone >10 nmol/L) at any time during the study period., Changes in B-cell count, auto-antibody indices, and immunoglobulin (IgG) levels from baseline to the end of the study period., Changes in serum follicle-stimulating hormone (FSH) and anti-Müllerian hormone (AMH) levels from baseline to the end of the study period., Changes in quality of life scores, as measured by validated instruments (AddiQol, PGWB, SF-36, and MRS), from baseline to the end of the study period., Safety endpoint: the incidence and severity of adverse events, hospital admissions, infections, allergic reactions and over stimulation in relation to the controlled ovarian hyperstimulation.

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Countries

Sweden

Outcome results

None listed