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Completed

NCT Number: NCT02572154

Sperm DNA Fragmentation in 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.

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Key information

Conditions

Recurrent Pregnancy Loss

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Chu Bordeaux, Bordeaux, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood and sperm samples

Other

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

Primary outcomes

  1. sperm DNA fragmentation

    Time frame: baseline

    Percentage of sperm with fragmented DNA in both groups

Secondary outcomes

  1. Sperm aneuploidy

    Time frame: baseline

    Percentage of spermatozoa with aneuploidy.

  2. Sperm Volume

    Time frame: baseline

  3. Sperm pH

    Time frame: baseline

  4. sperm concentration

    Time frame: baseline

  5. sperm concentration of round cells

    Time frame: baseline

  6. percentage of motile and morphologically normal spermatozoa in sperm

    Time frame: baseline

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

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

Acronym: PARTHOM

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Oct 8, 2015
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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