Sperm DNA Fragmentation in Recurrent Pregnancy Loss

Study Overview
=================
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.

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

Conditions
-----------------
RECURRENT PREGNANCY LOSS

Intervention / Treatment
-----------------
* Other: Blood and sperm samples


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cases<br>men from couples with RPL after natural pregnancies, had blood and sperm samples for sperm DNA fragmentation exploration | Other: Blood and sperm samples<br>* 20 ml of blood and sperm samples for sperm DNA fragmentation exploration<br>|
| Other: Controls<br>men from couples who have a child consequently to a natural pregnancy, had blood and sperm samples for sperm DNA fragmentation exploration | Other: Blood and sperm samples<br>* 20 ml of blood and sperm samples for sperm DNA fragmentation exploration<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sperm DNA fragmentation | Percentage of sperm with fragmented DNA in both groups | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm aneuploidy | Percentage of spermatozoa with aneuploidy. | baseline | 
| Sperm Volume |  | baseline | 
| Sperm pH |  | baseline | 
| sperm concentration |  | baseline | 
| sperm concentration of round cells |  | baseline | 
| percentage of motile and morphologically normal spermatozoa in sperm |  | baseline |