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N/A N=241 Randomized Treatment

Prednisolone Improves IVF Outcomes in Men With Anti-sperm Antibodies

Reproductive Sterility

Enrolled (actual)
241
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Number of Control and Treated Participants With Successful Live Births Following Conventional IVF or ICSI Cycles — 18; 13; 8; 9 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Prednisolone treatment (Drug)
Age
Adult · 25+ yrs
Sex
All
Sponsor
Barz IVF Center for Infertility Treatment and Embryo Research
Primary completion
Mar 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Control and Treated Participants With Successful Live Births Following Conventional IVF or ICSI Cycles
18; 13; 8; 9

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.

Eligibility Criteria

Inclusion Criteria

  • Female partners had complete or partial tubal patency
  • Male partners with anti-sperm antibodies
  • Male partners with sperm count > 35 million/ml.

Exclusion Criteria

  • Female partners with polycystic ovary
  • Female partners with endometriosis
  • Female partners with abnormal profile of reproductive hormones
  • Female partners with abnormal profile of thyroid hormones
  • Male partners with seminal fluid infections (e.g. leukospermia)
  • Male partners with abnormal profile of reproductive hormones
  • Male partners with abnormal profile of thyroid hormones
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02935738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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