Prednisolone Improves IVF Outcomes in Men With Anti-sperm Antibodies
Condition: Reproductive Sterility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Corticosteroids have been indicated to treat men with ASAs. Although many studies have
      confirmed the clinical therapeutic significance of corticosteroids in the treatment of men
      with ASAs, other studies have not found a therapeutic significance for corticosteroids in the
      treatment of men with ASAs. Moreover, although some reports have shown high fertilization and
      conception rates in couples when husbands did not have ASAs, other reports have shown that
      ASAs do not have a negative effect on fertilization and conception rates. These contradictory
      results have left the therapeutic effect of corticosteroids in men with ASA in continuing
      controversy. This controversy is also extended to include the usefulness of assisted
      reproductive technology (ART) in the treatment of patients with ASAs. In this regard,
      although some studies have shown that the pregnancy rate following in vitro fertilization
      (IVF) or intracellular sperm injection (ICSI) were similar in men with or without ASA or did
      not associate with ASA, others reported the superiority of ICSI over IVF and intrauterine
      insemination over natural intercourse in men with ASAs. It is possible that some patients
      with ASAs also have an additional problem(s) related to sperm binding to the oolemma and
      fusion into the ovum as well as sperm head decondensation. The latter condition may
      negatively influence or mask the clinical significance of corticosteroids on pregnancy rates
      in patients with ASAs. Some patients might not have benefited from corticosteroids and
      conventional IVF treatments due to the impaired sperm fusogenic capacity in addition to ASAs.
      Human sperm penetration assay (SPA), of the hamster oocyte free from zona pellucida, is a
      sensitive tool that can address such potential impairment of sperm binding with the oolemma
      and fusion into the oocyte as well as sperm head decondensation. Males with poor SPA results
      benefit from ICSI whereas those with good SPA results can still benefit from conventional
      IVF.

      The present study was therefore conducted to address the therapeutic usefulness of a
      corticosteroid named prednisolone in the treatment of immunologically infertile men
      undergoing IVF or ICSI determined by SPA.
    

Detailed description: 
      This prospective study was conducted at the Barz IVF Center for Infertility Treatment and
      Embryo Research, Erbil, Kurdistan Region, Iraq and the Baghdad University Teaching Hospital
      of the College of Medicine, University of Baghdad, Baghdad, Iraq between October 2014 and May
      2016. In all cases, the wife's ova were inseminated with the husband's semen samples.
      Identified men with positive ASAs were randomly assigned for treatment with or without
      prednisolone for three cycles. Infertile men were treated with prednisolone tablet, po, for
      21 days of their wife's menstrual cycles. Briefly, the prednisolone regimen was started with
      a dose of 5mg, tid, for two weeks followed by 5mg bid for five days. This was further tapered
      to one tablet of 5mg/day for two days. Patients were then given one week of rest from the
      treatment, before this prednisolone regimen was repeated for another two cycles

      Treated men that recovered from ASAs and control patients underwent SPA. Patients with
      positive or negative SPA results were then admitted to conventional IVF or ICSI cycles,
      respectively. Only the first embryo transfer cycle following IVF or ICSI was included in this
      analysis.
    

Intervention name(s): Prednisolone treatment
Intervention type(s): Drug
Intervention description(s): Infertile men were treated with prednisolone tablet, which is an intermediate acting corticosteroid, po, for 21 days of their wife's menstrual cycles. Briefly, the prednisolone regimen was started with a dose of 5mg, tid, for two weeks followed by 5mg bid for five days. This was further tapered to one tablet of 5mg/day for two days. Patients were then given one week of rest from the treatment, before this prednisolone regimen was repeated for another two cycles.
Other intervention name(s): Experimental
Intervention MeSH terms: Prednisolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prednisolone; anti-sperm antibodies; sperm penetration assay