Immunomodulatory Effects of Subcutaneous Progesterone in Patients Affected by Autoimmune Diseases

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04665232
• Other study ID #: San Carlo Public Hospital
• Status: Completed
• Start date: April 2014
• Est. completion date: April 2017

Study information

• Verified date: May 2024
• Source: San Carlo Public Hospital, Potenza, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

• Infertile patients affected by autoimmune diseases undergoing IVF

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Infertility

Intervention

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

Locations

Country	Name	City	State
Italy	Assunta Iuliano	Potenza

Sponsors (1)

Lead Sponsor	Collaborator
San Carlo Public Hospital, Potenza, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (8)

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. — View Citation

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. — View Citation

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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. Erratum In: Fertil Steril. 2006 Aug;86(2):498. Aghajnova, Lusine [corrected to Aghajanova, Lusine]. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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