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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02572154
Other study ID # 11 198 08
Secondary ID
Status Completed
Phase N/A
First received October 6, 2015
Last updated October 24, 2016
Start date September 2012
Est. completion date July 2015

Study information

Verified date October 2016
Source University Hospital, Toulouse
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 64
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 55 Years
Eligibility 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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Intervention

Other:
Blood and sperm samples
20 ml of blood and sperm samples for sperm DNA fragmentation exploration

Locations

Country Name City State
France Chu Bordeaux Bordeaux
France APHM Marseille
France Chu Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary sperm DNA fragmentation Percentage of sperm with fragmented DNA in both groups baseline No
Secondary Sperm aneuploidy Percentage of spermatozoa with aneuploidy. baseline No
Secondary Sperm Volume baseline No
Secondary Sperm pH baseline No
Secondary sperm concentration baseline No
Secondary sperm concentration of round cells baseline No
Secondary percentage of motile and morphologically normal spermatozoa in sperm baseline No
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