RECURRENT PREGNANCY LOSSPARTHOMNCT02572154
Sperm DNA Fragmentation in Recurrent Pregnancy Loss
A study testing Blood and sperm samples in people with RECURRENT PREGNANCY LOSS, run by University Hospital, Toulouse at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- RECURRENT PREGNANCY LOSS
- What is being tested?
- Blood and sperm samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 3 sitesFrance
- Study dates
- Sep 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
3 sites in 1 country.
About this study
Official 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.
- Conditions
- RECURRENT PREGNANCY LOSS
- Being tested
- Blood and sperm samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and sperm samplesOther
20 ml of blood and sperm samples for sperm DNA fragmentation exploration
| Study group | Role | What they receive |
|---|---|---|
| Cases | Other | men from couples with RPL after natural pregnancies, had blood and sperm samples for sperm DNA fragmentation exploration Receives: 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 Receives: Other: Blood and sperm samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
sperm DNA fragmentation
Percentage of sperm with fragmented DNA in both groups
Measured: baseline
Secondary outcomes (6)
Sperm aneuploidy
Percentage of spermatozoa with aneuploidy.
Measured: baseline
Sperm Volume
Measured: baseline
Sperm pH
Measured: baseline
sperm concentration
Measured: baseline
sperm concentration of round cells
Measured: baseline
percentage of motile and morphologically normal spermatozoa in sperm
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startSep 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RECURRENT PREGNANCY LOSSStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Louis Bujan, PUPH, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572154
- Sponsor's protocol ID
- 11 198 08
- Acronym
- PARTHOM
- Status last verified
- Oct 2016
- First submitted
- 6 Oct 2015
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29619224
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Male Factor in Early Recurrent Pregnancy Loss : Study of Sperm DNA Fragmentation in Patients With Unexplained Recurrent Pregnancy Loss.
- ClinicalTrials.gov ID
- NCT02572154
- Acronym / sponsor ID
- PARTHOM / 11 198 08
- Conditions
- RECURRENT PREGNANCY LOSS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | Other | Other: Blood and sperm samplesmen from couples with RPL after natural pregnancies, had blood and sperm samples for sperm DNA fragmentation exploration |
| Controls | Other | Other: Blood and sperm samplesmen from couples who have a child consequently to a natural pregnancy, had blood and sperm samples for sperm DNA fragmentation exploration |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and sperm samples20 ml of blood and sperm samples for sperm DNA fragmentation exploration | Other | Cases, Controls |
Primary outcome
sperm DNA fragmentation
Time frame: baseline
Percentage of sperm with fragmented DNA in both groups
6 secondary outcomes
Sperm aneuploidy
Time frame: baseline
Sperm Volume
Time frame: baseline
Sperm pH
Time frame: baseline
sperm concentration
Time frame: baseline
sperm concentration of round cells
Time frame: baseline
percentage of motile and morphologically normal spermatozoa in sperm
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Results publication: PubMed 29619224Esquerre-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Bujan, PUPH principal investigator
University Hospital, Toulouse
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood and sperm samples in people with RECURRENT PREGNANCY LOSS, run by University Hospital, Toulouse at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sperm DNA fragmentation (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02572154, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.