Clinical trial NCT04665232: Immunomodulatory Effects of Subcutaneous Progesterone in Patients Affected by Autoimmune Diseases
Official title: Immunomodulatory Effects of Subcutaneous Progesterone in Patients Undergoing IVF Affected by Autoimmune Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autoimmune Diseases
Infertility
Keywords: autoimmune diseases and infertility
luteal supplementation with subcutaneous progesterone
Systemic effect of progesterone
Lead sponsor: San Carlo Public Hospital, Potenza, Italy
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile patients affected by autoimmune diseases undergoing IVF

Brief summary: This study evaluates the immunomodulatory effects of subcutaneous progesterone in patients undergoing IVF by determination of anti-nuclear antibodies (ANA),extractable nuclear antigen antibodies (ENA),anti- neutrophil cytoplasmic antibodies(ANCA),anti-DNA antibodies, anti-cardiolipin antibodies (ACA),Lupus anticoagulant antibodies (LAC) and C3 and C4 fractions of complement on the day of beta hCG dosage and during the eigth week of gestation.

Detailed description: The aqueous progesterone preparation for s.c. injection is the first systemic progesterone of its kind for the provision of luteal phase support (LPS) in patients undergoing IVF.

The the high solubility and rapid absorption of the new preparation are enhanced using cyclodextrins that are starch residues with no therapeutic activity and with a particular molecular structure that closely resembles a 'cap'.

Once absorbed after injection, the progesterone molecule is immediately dissociated from its cyclodextrin 'cap', remaining free in the circulation as if produced endogenously by the ovaries.

In comparison to progesterone-in-oil preparation, the new aqueous solution administered by s.c.route resulted in a 3 fold higher and more rapid progesterone peak serum concentrations.

The immunomodulating effects of progesterone are mediated outside of the pelvic cavity, on the peripheral cell of the immune system. For this reason only the injection procedure has this advantage Furthermore, the faster absorption rate and the higher peak serum concentration should increas the systemic immunomodulatory effect of subcutaneous progesterone compared to the vaginal and intramuscular administration

Eligibility criteria: Inclusion Criteria:

* Infertile patients affected by autoimmune diseases undergoing IVF

Exclusion Criteria:

* infertile patients without autoimmune diseases, fertile patients affected by autoimmune diseases

Primary outcomes:
measure: Pregnancy Rate percentage, Implantation Rate percentage, Live Birth Rate percentage
timeFrame: 12 mounths
Secondary outcomes:
Other outcomes:
Locations:
city: Potenza
country: Italy
facility: Assunta Iuliano
Study officials:
affiliation: San Carlo Public Hospital, Potenza, Italy
name: Assunta Iuliano, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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