Trial Outcomes & Findings for Prednisolone Improves IVF Outcomes in Men With Anti-sperm Antibodies (NCT NCT02935738)
NCT ID: NCT02935738
Last Updated: 2020-11-16
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
241 participants
Primary outcome timeframe
Nine months (pregnancy term) after the in vitro fertilization.
Results posted on
2020-11-16
Participant Flow
Participant milestones
| Measure |
Prednisolone Treated Men / Positive SPA / IVF
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.
|
Prednisolone Treated Men / Negative SPA / ICSI
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.
Prednisolone 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
|
Control Men / Positive SPA / IVF
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.
|
Control Men / Negative SPA / ICSI
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
67
|
74
|
47
|
53
|
|
Overall Study
COMPLETED
|
50
|
53
|
46
|
48
|
|
Overall Study
NOT COMPLETED
|
17
|
21
|
1
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prednisolone Improves IVF Outcomes in Men With Anti-sperm Antibodies
Baseline characteristics by cohort
| Measure |
The Clinical Data of Control Men Underwent IVF
n=46 Participants
|
The Clinical Data of Treated Men Underwent IVF
n=50 Participants
|
The Clinical Data of Control Men Underwent ICSI
n=48 Participants
|
The Clinical Data of Treated Men Underwent ICSI
n=53 Participants
|
Total
n=197 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
46 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
53 Participants
n=483 Participants
|
197 Participants
n=36 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Age, Continuous
Age
|
36.2 years
STANDARD_DEVIATION 7.8 • n=93 Participants
|
37.9 years
STANDARD_DEVIATION 5.8 • n=4 Participants
|
34.5 years
STANDARD_DEVIATION 3.8 • n=27 Participants
|
34.2 years
STANDARD_DEVIATION 2.9 • n=483 Participants
|
35.7 years
STANDARD_DEVIATION 5.1 • n=36 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
53 Participants
n=483 Participants
|
197 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
53 Participants
n=483 Participants
|
197 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
53 Participants
n=483 Participants
|
197 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
Iraq
|
46 Participants
n=93 Participants
|
50 Participants
n=4 Participants
|
48 Participants
n=27 Participants
|
53 Participants
n=483 Participants
|
197 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Nine 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
Outcome measures
| Measure |
Prednisolone Treated Men / Positive SPA / IVF
n=50 Participants
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.
|
Prednisolone Treated Men / Negative SPA / ICSI
n=53 Participants
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.
|
Control Men / Positive SPA / IVF
n=46 Participants
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.
|
Control Men / Negative SPA / ICSI
n=48 Participants
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.
|
|---|---|---|---|---|
|
Number of Control and Treated Participants With Successful Live Births Following Conventional IVF or ICSI Cycles
|
18 participants
|
13 participants
|
8 participants
|
9 participants
|
Adverse Events
Prednisolone Treated Men / Positive SPA / IVF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Prednisolone Treated Men / Negative SPA / ICSI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Men / Positive SPA / IVF
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Men / Negative SPA / ICSI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Saeeda A. Muhsen-Alanssari
Barz IVF Center for Embryo Research and Infertility Treatment
Phone: 9798201303
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place