RECURRENT PREGNANCY LOSS Clinical Trial
— PARTHOMOfficial title:
Male Factor in Early Recurrent Pregnancy Loss : Study of Sperm DNA Fragmentation in Patients With Unexplained Recurrent Pregnancy Loss.
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.
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 |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
France | Chu Bordeaux | Bordeaux | |
France | APHM | Marseille | |
France | Chu Toulouse | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
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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