Immunomodulatory Effects of Subcutaneous Progesterone in Patients Affected by Autoimmune Diseases

Study Overview
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Brief Summary
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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
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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

Official Title
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Immunomodulatory Effects of Subcutaneous Progesterone in Patients Undergoing IVF Affected by Autoimmune Diseases

Conditions
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Autoimmune Diseases, Infertility

Intervention / Treatment
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* Drug: aqueous subcutaneous progesterone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Infertile patients affected by autoimmune diseases undergoing IVF Exclusion Criteria: infertile patients without autoimmune diseases, fertile patients affected by autoimmune diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients affected by autoimmune diseases<br>Infertile patients suffering from autoimmune diseases to be subjected to IVF in which the luteal phase has been supplemented with 25 mg /die of aqueous subcutaneous progesterone | Drug: aqueous subcutaneous progesterone<br>* 25 mg/die of aqueous subcutaneous progesterone from the day of oocytes retrieval for two weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy Rate percentage, Implantation Rate percentage, Live Birth Rate percentage | number of pregnancies / 100 embryotransfer, number of implanted embryos/ number of embryos trafsferred, number of live birth | After two weeks from oocytes retrieval until the birth of baby | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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autoimmune diseases and infertility, luteal supplementation with subcutaneous progesterone, Systemic effect of progesterone