Immunomodulatory Effects of Subcutaneous Progesterone in Patients Affected by Autoimmune Diseases

Completed

• Conditions: Autoimmune Diseases; Infertility
• Interventions: Drug: aqueous subcutaneous progesterone

• Registration Number: NCT04665232
• Lead Sponsor: San Carlo Public Hospital, Potenza, Italy

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

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2016-02-25
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Study First Submitted QC: 2020-12-06
• Study First Posted: 2020-12-11
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

• Infertile patients affected by autoimmune diseases undergoing IVF

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients affected by autoimmune diseases	aqueous subcutaneous progesterone	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

Primary Outcome Measures

Name	Time	Method
Pregnancy Rate percentage, Implantation Rate percentage, Live Birth Rate percentage	12 mounths	number of pregnancies / 100 embryotransfer, number of implanted embryos/ number of embryos trafsferred, number of live birth

Trial Locations

Locations (1)

Assunta Iuliano; 🇮🇹 Potenza, Italy