Sperm DNA Fragmentation in Recurrent Pregnancy Loss

RECURRENT PREGNANCY LOSS Clinical Trial

— PARTHOM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572154
• Other study ID #: 11 198 08
• 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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Fetal Death
• RECURRENT PREGNANCY LOSS

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