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Prednisolone Improves IVF Outcomes in Men With Anti-sperm Antibodies

Improvement in Pregnancy Outcomes in Immunologically Infertile Male Patients Undergoing Prednisolone Treatment and Conventional IVF Preceded by Sperm Penetration Assay: A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02935738
Enrollment
241
Registered
2016-10-17
Start date
2014-10-31
Completion date
2016-05-31
Last updated
2020-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reproductive Sterility

Keywords

prednisolone, anti-sperm antibodies, sperm penetration assay

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.

Interventions

DRUGPrednisolone treatment

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.

Sponsors

University of Baghdad
CollaboratorOTHER
Barz IVF Center for Infertility Treatment and Embryo Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Control and Treated Participants With Successful Live Births Following Conventional IVF or ICSI CyclesNine months (pregnancy term) after the in vitro fertilization.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

Participant flow

Participants by arm

ArmCount
The Clinical Data of Control Men Underwent IVF46
The Clinical Data of Treated Men Underwent IVF50
The Clinical Data of Control Men Underwent ICSI48
The Clinical Data of Treated Men Underwent ICSI53
Total197

Baseline characteristics

CharacteristicThe Clinical Data of Control Men Underwent IVFThe Clinical Data of Treated Men Underwent IVFThe Clinical Data of Control Men Underwent ICSIThe Clinical Data of Treated Men Underwent ICSITotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
46 Participants50 Participants48 Participants53 Participants197 Participants
Age, Continuous
Age
36.2 years
STANDARD_DEVIATION 7.8
37.9 years
STANDARD_DEVIATION 5.8
34.5 years
STANDARD_DEVIATION 3.8
34.2 years
STANDARD_DEVIATION 2.9
35.7 years
STANDARD_DEVIATION 5.1
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants0 Participants0 Participants0 Participants0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
46 Participants50 Participants48 Participants53 Participants197 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
46 Participants50 Participants48 Participants53 Participants197 Participants
Region of Enrollment
Iraq
46 Participants50 Participants48 Participants53 Participants197 Participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Male
46 Participants50 Participants48 Participants53 Participants197 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 500 / 530 / 460 / 48
other
Total, other adverse events
0 / 500 / 530 / 460 / 48
serious
Total, serious adverse events
0 / 500 / 530 / 460 / 48

Outcome results

Primary

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

Time frame: Nine months (pregnancy term) after the in vitro fertilization.

ArmMeasureValue (NUMBER)
Prednisolone Treated Men / Positive SPA / IVFNumber of Control and Treated Participants With Successful Live Births Following Conventional IVF or ICSI Cycles18 participants
Prednisolone Treated Men / Negative SPA / ICSINumber of Control and Treated Participants With Successful Live Births Following Conventional IVF or ICSI Cycles13 participants
Control Men / Positive SPA / IVFNumber of Control and Treated Participants With Successful Live Births Following Conventional IVF or ICSI Cycles8 participants
Control Men / Negative SPA / ICSINumber of Control and Treated Participants With Successful Live Births Following Conventional IVF or ICSI Cycles9 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026