Skip to content

Sperm DNA Fragmentation in Recurrent Pregnancy Loss

Male Factor in Early Recurrent Pregnancy Loss : Study of Sperm DNA Fragmentation in Patients With Unexplained Recurrent Pregnancy Loss.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02572154
Acronym
PARTHOM
Enrollment
64
Registered
2015-10-08
Start date
2012-09-30
Completion date
2015-07-31
Last updated
2025-12-15

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

Conditions

RECURRENT PREGNANCY LOSS

Brief summary

In human, 2% of couples experimented Recurrent pregnancy loss (RPL). Currently, while etiological investigations were performed, 40 to 50 % of RPL were unexplained. In animals' studies, several studies have underlined the importance of sperm quality for a normal embryo development. In human, epidemiological studies have demonstrated that several male risk factors have effects on development (male mediated development toxicology). However, few studies have explored sperm DNA fragmentation on embryo development but after in vitro fertilization. In natural pregnancy only rare studies have been performed but with different populations definitions and different methods of sperm exploration. In this context sperm DNA fragmentation exploration appears justified. The present study purpose to conduct a case - control study in order to research paternal role in RPL.

Interventions

20 ml of blood and sperm samples for sperm DNA fragmentation exploration

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

* Cases: Man from couples with RPL (more than 2 miscarriages) RPL classical etiological exploration negative (unexplained RPL) Healthy voluntaries * Control: Man from couples who have a child after a natural pregnancy obtained in the year following child desire. Healthy voluntaries

Exclusion criteria

* Cases: Etiological exploration of RPL positive Man with chromosomal anomaly * Cases and controls: Ongoing pathology Chemotherapy or radiotherapy history Hyperthermia (fever) in the last three months Pregnancy obtained by assisted reproduction (Inseminations, in vitro fertilization) Women \> 38 year old

Design outcomes

Primary

MeasureTime frameDescription
sperm DNA fragmentationbaselinePercentage of sperm with fragmented DNA in both groups

Secondary

MeasureTime frameDescription
Sperm Volumebaseline
Sperm pHbaseline
Sperm aneuploidybaselinePercentage of spermatozoa with aneuploidy.
sperm concentration of round cellsbaseline
percentage of motile and morphologically normal spermatozoa in spermbaseline
sperm concentrationbaseline

Countries

France

Outcome results

None listed

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