Sperm DNA Fragmentation in Recurrent Pregnancy Loss

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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RECURRENT PREGNANCY LOSS

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cases

men from couples with RPL after natural pregnancies, had blood and sperm samples for sperm DNA fragmentation exploration

Group Type OTHER

Blood and sperm samples

Intervention Type OTHER

20 ml of blood and sperm samples for sperm DNA fragmentation exploration

Controls

men from couples who have a child consequently to a natural pregnancy, had blood and sperm samples for sperm DNA fragmentation exploration

Group Type OTHER

Blood and sperm samples

Intervention Type OTHER

20 ml of blood and sperm samples for sperm DNA fragmentation exploration

Interventions

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Blood and sperm samples

20 ml of blood and sperm samples for sperm DNA fragmentation exploration

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes