NCT02572154

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
Last Updated

December 15, 2025

Status Verified

October 1, 2016

Enrollment Period

2.8 years

First QC Date

October 6, 2015

Last Update Submit

December 5, 2025

Conditions

RECURRENT PREGNANCY LOSS

Outcome Measures

Primary Outcomes (1)

  • sperm DNA fragmentation

    Percentage of sperm with fragmented DNA in both groups

    baseline

Secondary Outcomes (6)

  • Sperm aneuploidy

    baseline

  • Sperm Volume

    baseline

  • Sperm pH

    baseline

  • sperm concentration

    baseline

  • sperm concentration of round cells

    baseline

  • +1 more secondary outcomes

Study Arms (2)

Cases

OTHER

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

Other: Blood and sperm samples

Controls

OTHER

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

Other: Blood and sperm samples

Interventions

Blood and sperm samplesOTHER

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

CasesControls

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Chu Bordeaux

Bordeaux, France

Location

APHM

Marseille, France

Location

Chu Toulouse

Toulouse, France

Location

Related Publications (1)

  • Esquerre-Lamare C, Walschaerts M, Chansel Debordeaux L, Moreau J, Bretelle F, Isus F, Karsenty G, Monteil L, Perrin J, Papaxanthos-Roche A, Bujan L. Sperm aneuploidy and DNA fragmentation in unexplained recurrent pregnancy loss: a multicenter case-control study. Basic Clin Androl. 2018 Apr 2;28:4. doi: 10.1186/s12610-018-0070-6. eCollection 2018.

    PMID: 29619224RESULT

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Louis Bujan, PUPH

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 8, 2015

Study Start

September 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

December 15, 2025

Record last verified: 2016-10

Locations

FR(3)