Sperm DNA Fragmentation in Recurrent Pregnancy Loss

Not Applicable

Completed

• Conditions: RECURRENT PREGNANCY LOSS
• Interventions: Other: Blood and sperm samples

• Registration Number: NCT02572154
• Lead Sponsor: University Hospital, Toulouse

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Study First Submitted: 2015-10-06
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Controls	Blood and sperm samples	men from couples who have a child consequently to a natural pregnancy, had blood and sperm samples for sperm DNA fragmentation exploration
Cases	Blood and sperm samples	men from couples with RPL after natural pregnancies, had blood and sperm samples for sperm DNA fragmentation exploration

Primary Outcome Measures

Name	Time	Method
sperm DNA fragmentation	baseline	Percentage of sperm with fragmented DNA in both groups

Secondary Outcome Measures

Name	Time	Method
Sperm Volume	baseline
sperm concentration	baseline
Sperm aneuploidy	baseline	Percentage of spermatozoa with aneuploidy.
Sperm pH	baseline
percentage of motile and morphologically normal spermatozoa in sperm	baseline
sperm concentration of round cells	baseline

Trial Locations

Locations (3)

Chu Bordeaux; 🇫🇷 Bordeaux, France

APHM; 🇫🇷 Marseille, France

Chu Toulouse; 🇫🇷 Toulouse, France