Trial Outcomes & Findings for Impact of DNA Fragmentation in Sperm on Pregnancy Outcome After Intra-uterine Insemination in a Spontaneous Cycle (NCT NCT03319654)

NCT ID: NCT03319654

Last Updated: 2024-11-15

Results Overview

The odds ratio on live birth per unit increase in % total Sperm DNA Fragmentation of the diagnostic sample.

Recruitment status

COMPLETED

Study phase

Target enrollment

120 participants

Primary outcome timeframe

up to 36 months

Results posted on

2024-11-15

Participant Flow

Centre for Reproductive Medicine of the Antwerp University Hospital, Belgium

6 included patients did not proceed to treatment; 1 due to spontaneous pregnancy - 5 loss to follow-up

Participant milestones

Participant milestones
Measure	Spontaneous Cycle IUI DNA fragmentation by TUNEL assay DNA fragmentation will be measured both at the time of the diagnostic work-up as at the time of insemination. DNA fragmentation by TUNEL assay: Direct DNA fragmentation testing with terminal deoxyuridine nick end labeling (TUNEL) assay.
Overall Study STARTED	114
Overall Study COMPLETED	114
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

114 couples were included

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Spontaneous Cycle IUI n=228 Participants The couples underwent natural cycle IUI with or without ovulation trigger until pregnancy was achieved for a maximum of four cycles. DNA fragmentation was measured by TUNEL assay.
Age, Continuous Women	30.3 years STANDARD_DEVIATION 3.7 • n=114 Participants • 114 couples were included
Age, Continuous Men	32.8 years STANDARD_DEVIATION 5.3 • n=114 Participants • 114 couples were included
Sex: Female, Male Female	114 Participants n=228 Participants
Sex: Female, Male Male	114 Participants n=228 Participants
Infertility Duration	23.3 months STANDARD_DEVIATION 12.4 • n=228 Participants
Sperm concentration	48 Million spermatozoa /ml ejaculate STANDARD_DEVIATION 63.7 • n=113 Participants • This pertains to 113 men (out of the 114 included). Rarely, patients did not have a diagnostic sperm analysis at our center but elsewhere.
Sperm progressive motility	55 % progessively motile spermatozoa STANDARD_DEVIATION 16 • n=113 Participants • This pertains to 113 men (out of the 114 included). Rarely, patients did not have a diagnostic sperm analysis at our center but elsewhere.
Abstinence period	4 days STANDARD_DEVIATION 2 • n=113 Participants • This pertains to 113 men (out of the 114 included). Rarely, patients did not have a diagnostic sperm analysis at our center but elsewhere.
Semen volume	3.7 ml ejaculate STANDARD_DEVIATION 2.3 • n=113 Participants • This pertains to 113 men (out of the 114 included). Rarely, patients did not have a diagnostic sperm analysis at our center but elsewhere.
Total sperm count	165.2 Million spermatozoa STANDARD_DEVIATION 199 • n=113 Participants • This pertains to 113 men (out of the 114 included). Rarely, patients did not have a diagnostic sperm analysis at our center but elsewhere.
Sperm ideal morphology	5 % of total sperm count STANDARD_DEVIATION 5 • n=113 Participants • This pertains to 113 men (out of the 114 included). Rarely, patients did not have a diagnostic sperm analysis at our center but elsewhere.
% SDF total in ejaculate	9 % of spermatozoa with SDF in ejaculate STANDARD_DEVIATION 7.2 • n=104 Participants • 104 men had a diagnostic sperm analysis with measurement of Sperm DNA fragmentation.
% SDF vital in ejaculate	1 % of vital sperm with SDF in ejaculate STANDARD_DEVIATION 0.9 • n=104 Participants • 104 men had a diagnostic sperm analysis with measurement of Sperm DNA fragmentation.
Mean menstrual cycle length	29 days STANDARD_DEVIATION 2 • n=111 Participants • Data available of 111 out of 114 included wommen

PRIMARY outcome

Timeframe: up to 36 months

The odds ratio on live birth per unit increase in % total Sperm DNA Fragmentation of the diagnostic sample.

Outcome measures

Outcome measures
Measure	Spontaneous Cycle IUI - Sperm DNA Fragmentation Analysis n=114 Participants 114 couples underwent natural cycle IUI with or without ovulation trigger until pregnancy was achieved for a maximum of four cycles.
DNA Fragmentation as a Predictor of Live Birth Rate	32 Participants

SECONDARY outcome

Timeframe: up to 3 months

% of spermatozoa with DNA fragmentation in the total fraction after density gradient in the diagnostic sample (pre-IUI)

Outcome measures

Outcome measures
Measure	Spontaneous Cycle IUI - Sperm DNA Fragmentation Analysis n=102 Participants 114 couples underwent natural cycle IUI with or without ovulation trigger until pregnancy was achieved for a maximum of four cycles.
% SDF in the Total Fraction After Density Gradient in the Diagnostic Sample (Pre-IUI)	9.6 % of spermatozoa with SDF Interval 4.6 to 20.1

SECONDARY outcome

Timeframe: up to 3 months

% of spermatozoa with DNA fragmentation in the vital fraction after density gradient in the diagnostic sample (pre-IUI)

Outcome measures

Outcome measures
Measure	Spontaneous Cycle IUI - Sperm DNA Fragmentation Analysis n=102 Participants 114 couples underwent natural cycle IUI with or without ovulation trigger until pregnancy was achieved for a maximum of four cycles.
% SDF in the Vital Fraction After Density Gradient in the Diagnostic Sample (Pre-IUI)	0.6 % of spermatozoa with SDF Interval 0.2 to 1.0

SECONDARY outcome

Timeframe: 36 months

Population: number of semen samples for IUI analyzed for sperm DNA fragmentation before density gradient

% of spermatozoa with DNA fragmentation in the total fraction in the ejaculate (before density gradient) of the IUI-sample

Outcome measures

Outcome measures
Measure	Spontaneous Cycle IUI - Sperm DNA Fragmentation Analysis n=209 Participants 114 couples underwent natural cycle IUI with or without ovulation trigger until pregnancy was achieved for a maximum of four cycles.
% SDF in the Total Fraction in the Ejaculate of the IUI- Sample	8 % of spermatozoa with SDF Interval 5.0 to 12.0

SECONDARY outcome

Timeframe: 36 months

Population: number of semen samples for IUI analyzed for sperm DNA fragmentation before density gradient

% of spermatozoa with DNA fragmentation in the vital fraction in the ejaculate (before density gradient) of the IUI-sample

Outcome measures

Outcome measures
Measure	Spontaneous Cycle IUI - Sperm DNA Fragmentation Analysis n=209 Participants 114 couples underwent natural cycle IUI with or without ovulation trigger until pregnancy was achieved for a maximum of four cycles.
% SDF in the Vital Fraction in the Ejaculate of the IUI- Sample	1 % of spermatozoa with SDF Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 36 months

Population: number of semen samples for IUI analyzed for SDF after density gradient

% of spermatozoa with DNA fragmentation in the total fraction after density gradient in the IUI sample

Outcome measures

Outcome measures
Measure	Spontaneous Cycle IUI - Sperm DNA Fragmentation Analysis n=210 Participants 114 couples underwent natural cycle IUI with or without ovulation trigger until pregnancy was achieved for a maximum of four cycles.
% SDF in the Total Fraction After Density Gradient in the IUI Sample	8.3 % of spermatozoa with SDF Interval 4.0 to 14.0

SECONDARY outcome

Timeframe: 36 months

Population: number of semen samples for IUI analyzed for SDF after density gradient

% of spermatozoa with DNA fragmentation in the vital fraction after density gradient in the IUI sample

Outcome measures

Outcome measures
Measure	Spontaneous Cycle IUI - Sperm DNA Fragmentation Analysis n=210 Participants 114 couples underwent natural cycle IUI with or without ovulation trigger until pregnancy was achieved for a maximum of four cycles.
% SDF in the Vital Fraction After Density Gradient in the IUI Sample	0.4 % of spermatozoa with SDF Interval 0.2 to 1.0

Adverse Events

Spontaneous Cycle IUI - Sperm DNA Fragmentation Analysis

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. Alessa Sugihara

Antwerp University Hospital, Belgium

Phone: 00328213684

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place