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Sperm DNA Fragmentation in Recurrent Pregnancy Loss (PARTHOM)

T

Toulouse University Hospital

Status

Completed

Conditions

RECURRENT PREGNANCY LOSS

Treatments

Other: Blood and sperm samples

Study type

Interventional

Funder types

Other

Identifiers

NCT02572154
11 198 08

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

64 participants in 2 patient groups

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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