Immunomodulatory Effects of Subcutaneous Progesterone in Patients Affected by Autoimmune Diseases

NCT04665232 | Completed

• 1 other identifier: San Carlo Public Hospital
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Diseases; Infertility

Keywords

autoimmune diseases and infertility; luteal supplementation with subcutaneous progesterone; Systemic effect of progesterone

Outcome Measures

Primary Outcomes (1)

• 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

  12 mounths

Study Arms (1)

Patients affected by autoimmune diseases

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

Interventions

aqueous subcutaneous progesterone DRUG

25 mg/die of aqueous subcutaneous progesterone from the day of oocytes retrieval for two weeks.

Patients affected by autoimmune diseases

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Infertile patients affected by autoimmune diseases undergoing IVF

You may qualify if:

• Infertile patients affected by autoimmune diseases undergoing IVF

You may not qualify if:

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

Sponsors & Collaborators

• San Carlo Public Hospital, Potenza, Italy: lead

Study Sites (1)

Assunta Iuliano

Potenza, 85100, Italy

Location

Related Publications (8)

• Paulson RJ. Hormonal induction of endometrial receptivity. Fertil Steril. 2011 Sep;96(3):530-5. doi: 10.1016/j.fertnstert.2011.07.1097.

  PMID: 21880274 BACKGROUND

• de Ziegler D, Sator M, Binelli D, Leuratti C, Cometti B, Bourgain C, Fu YS, Garhofer G. A randomized trial comparing the endometrial effects of daily subcutaneous administration of 25 mg and 50 mg progesterone in aqueous preparation. Fertil Steril. 2013 Sep;100(3):860-6. doi: 10.1016/j.fertnstert.2013.05.029. Epub 2013 Jun 24.

  PMID: 23806850 BACKGROUND

• Practice Committee of the American Society for Reproductive Medicine. Current clinical irrelevance of luteal phase deficiency: a committee opinion. Fertil Steril. 2015 Apr;103(4):e27-32. doi: 10.1016/j.fertnstert.2014.12.128. Epub 2015 Feb 11.

  PMID: 25681857 BACKGROUND

• Fatemi HM. The luteal phase after 3 decades of IVF: what do we know? Reprod Biomed Online. 2009;19 Suppl 4:4331.

  PMID: 20034417 BACKGROUND

• Stavreus-Evers A, Mandelin E, Koistinen R, Aghajanova L, Hovatta O, Seppala M. Glycodelin is present in pinopodes of receptive-phase human endometrium and is associated with down-regulation of progesterone receptor B. Fertil Steril. 2006 Jun;85(6):1803-11. doi: 10.1016/j.fertnstert.2005.12.018.

  PMID: 16759928 BACKGROUND

• Lim KJ, Odukoya OA, Ajjan RA, Li TC, Weetman AP, Cooke ID. The role of T-helper cytokines in human reproduction. Fertil Steril. 2000 Jan;73(1):136-42. doi: 10.1016/s0015-0282(99)00457-4.

  PMID: 10632428 BACKGROUND

• Faas M, Bouman A, Moesa H, Heineman MJ, de Leij L, Schuiling G. The immune response during the luteal phase of the ovarian cycle: a Th2-type response? Fertil Steril. 2000 Nov;74(5):1008-13. doi: 10.1016/s0015-0282(00)01553-3.

  PMID: 11056250 BACKGROUND

• Rier SE. Environmental immune disruption: a comorbidity factor for reproduction? Fertil Steril. 2008 Feb;89(2 Suppl):e103-8. doi: 10.1016/j.fertnstert.2007.12.040.

  PMID: 18308048 BACKGROUND

Related Links

• The luteal phase after 3 decades of IVF: what do we know? HM Fatemi, Vol.19 Suppl. 4, 2009 Reproductive BioMedicine Online

MeSH Terms

Conditions

Autoimmune Diseases; Infertility

Condition Hierarchy (Ancestors)

Immune System Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Assunta Iuliano, MD,PhD

  San Carlo Public Hospital, Potenza, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 25, 2016
• First Posted: December 11, 2020
• Study Start: April 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 30 years
• Access Criteria: Archive of Medically Assisted Procreation of San Carlo Hospital

Locations

IT (1)