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Prednisolone Improves IVF Outcomes in Men With Anti-sperm Antibodies

Primary Purpose

Reproductive Sterility

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prednisolone treatment
Sponsored by
Barz IVF Center for Infertility Treatment and Embryo Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reproductive Sterility focused on measuring prednisolone, anti-sperm antibodies, sperm penetration assay

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    No Intervention

    No Intervention

    Arm Label

    Prednisolone treated men / positive SPA / IVF

    Prednisolone treated men / negative SPA / ICSI

    Control men / positive SPA / IVF

    Control men / negative SPA / ICSI

    Arm Description

    Infertile men, with anti-sperm antibodies, 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. Prednisolone treated men, who recovered from anti-sperm antibodies, underwent then sperm penetration assay (SPA) using zona-free hamster ova. Couples with male partners having positive SPA results (greater than five) were admitted to conventional in vitro fertilization (IVF) cycles.

    Infertile men, with anti-sperm antibodies, 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. Prednisolone treated men, who recovered from anti-sperm antibodies, underwent then sperm penetration assay (SPA) using zona-free hamster ova. Couples with male partners having negative SPA results (equal or less than five) were admitted to intracytoplasmic sperm injection (ICSI) cycles.

    Infertile men with anti-sperm antibodies who were not treated with prednisolone, which is an intermediate acting corticosteroid, underwent sperm penetration assay (SPA) using zona-free hamster ova. Couples with male partners having positive SPA results (more than five) were then admitted to in vitro fertilization (IVF) cycle.

    Infertile men with anti-sperm antibodies who were not treated with prednisolone, which is an intermediate acting corticosteroid, underwent sperm penetration assay (SPA) using zona-free hamster ova. Couples with male partners having negative SPA results (equal or less than five) were then admitted to intracytoplasmic sperm injection (ICSI) cycles.

    Outcomes

    Primary Outcome Measures

    Number of Control and Treated Participants With Successful Live Births Following Conventional IVF or ICSI Cycles
    Live birth rates in treated and control patients undergoing conventional IVF or ICSI cycles as determined by the sperm penetration assay (SPA) of hamster zone free ova

    Secondary Outcome Measures

    Full Information

    First Posted
    October 11, 2016
    Last Updated
    October 22, 2020
    Sponsor
    Barz IVF Center for Infertility Treatment and Embryo Research
    Collaborators
    University of Baghdad
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02935738
    Brief Title
    Prednisolone Improves IVF Outcomes in Men With Anti-sperm Antibodies
    Official Title
    Improvement in Pregnancy Outcomes in Immunologically Infertile Male Patients Undergoing Prednisolone Treatment and Conventional IVF Preceded by Sperm Penetration Assay: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2014 (undefined)
    Primary Completion Date
    March 2016 (Actual)
    Study Completion Date
    May 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Barz IVF Center for Infertility Treatment and Embryo Research
    Collaborators
    University of Baghdad

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Reproductive Sterility
    Keywords
    prednisolone, anti-sperm antibodies, sperm penetration assay

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    241 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Prednisolone treated men / positive SPA / IVF
    Arm Type
    Experimental
    Arm Description
    Infertile men, with anti-sperm antibodies, 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. Prednisolone treated men, who recovered from anti-sperm antibodies, underwent then sperm penetration assay (SPA) using zona-free hamster ova. Couples with male partners having positive SPA results (greater than five) were admitted to conventional in vitro fertilization (IVF) cycles.
    Arm Title
    Prednisolone treated men / negative SPA / ICSI
    Arm Type
    Experimental
    Arm Description
    Infertile men, with anti-sperm antibodies, 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. Prednisolone treated men, who recovered from anti-sperm antibodies, underwent then sperm penetration assay (SPA) using zona-free hamster ova. Couples with male partners having negative SPA results (equal or less than five) were admitted to intracytoplasmic sperm injection (ICSI) cycles.
    Arm Title
    Control men / positive SPA / IVF
    Arm Type
    No Intervention
    Arm Description
    Infertile men with anti-sperm antibodies who were not treated with prednisolone, which is an intermediate acting corticosteroid, underwent sperm penetration assay (SPA) using zona-free hamster ova. Couples with male partners having positive SPA results (more than five) were then admitted to in vitro fertilization (IVF) cycle.
    Arm Title
    Control men / negative SPA / ICSI
    Arm Type
    No Intervention
    Arm Description
    Infertile men with anti-sperm antibodies who were not treated with prednisolone, which is an intermediate acting corticosteroid, underwent sperm penetration assay (SPA) using zona-free hamster ova. Couples with male partners having negative SPA results (equal or less than five) were then admitted to intracytoplasmic sperm injection (ICSI) cycles.
    Intervention Type
    Drug
    Intervention Name(s)
    Prednisolone treatment
    Other Intervention Name(s)
    Experimental
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Number of Control and Treated Participants With Successful Live Births Following Conventional IVF or ICSI Cycles
    Description
    Live birth rates in treated and control patients undergoing conventional IVF or ICSI cycles as determined by the sperm penetration assay (SPA) of hamster zone free ova
    Time Frame
    Nine months (pregnancy term) after the in vitro fertilization.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Saeeda A. Muhsen, DVM, PhD
    Organizational Affiliation
    Barz IVF Center for Infertility Treatment and Embryo Research
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
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    8902446
    Citation
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    Prednisolone Improves IVF Outcomes in Men With Anti-sperm Antibodies

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