ObesityBARIASPERMNCT01842295
Bariatric Surgery and Sperm Quality
A study testing Blood and sperm samples in people with Obesity and Bariatric Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to evaluate the impact of a bariatric surgery (gastric banding, bypass, sleeve gastrectomy) on several parameters (quality of sperm and others biological parameters, lifestyle, quality of life) involved in fertility of obese adult men. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- Obesity, Bariatric Surgery
- What is being tested?
- Blood and sperm samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 15 Feb 2013to 25 Mar 2016
- 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 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Obese men with BMI ≥ 40kg/m² or 35 kg/m² with associated co-morbidities
- Selected for bariatric surgery by multidisciplinary team
- From 18 to 50 years old included
- With a first medical consultation and its results
- With their written informed consent to participate in the study
- No problem for understanding verbal or written French
- An affiliation to social security
Who cannot join
- Not candidates for surgery
- With non idiopathic alteration of spermatogenesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bariatric Surgery, Nutrition, and Sperm Quality of Adult Obese Men on Childbearing Age : A Multicentric Cohort Study
The purpose of this study is to evaluate the impact of a bariatric surgery (gastric banding, bypass, sleeve gastrectomy) on several parameters (quality of sperm and others biological parameters, lifestyle, quality of life) involved in fertility of obese adult men.
Read the detailed description
In order to assess how bariatric surgery may influence their fertility parameters, patients will attend to 3 visits :
First visit (inclusion, before surgery) :
- Signature of consent
- Patient interview (Collection of data on background, treatments, socio-demographic characteristics, social and familial environment, food consumption and habits, tobacco and alcohol use, physical activity, libido and quality of life (surveys))
- Clinical examination and anthropometric assessment (BMI, blood pressure, expired CO)
- Blood samples (Metabolic and nutritional plasmatic biomarkers ; Plasmatic oxidative stress biomarkers ; antioxidants micronutrients ; hormones of adiposity and inflammation ; sex hormones ; persistent contaminants)
- Sperm sample (sperm count-morphology ; DNA fragmentation ; CASA)
Bariatric surgery
Second visit (6 month follow-up)
- Report of adverse events if any
- Surveys
- Blood and sperm samples
Third visit (12 month follow-up)
- Report of adverse events if any
- Blood and sperm samples
- Conditions
- Obesity, Bariatric Surgery
- Being tested
- Blood and sperm samples
- Keywords
- Obesity, Bariatric surgery, Sperm quality, Fertility
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and sperm samplesOther
Blood and sperm samples will be done in each visit
| Study group | Role | What they receive |
|---|---|---|
| Bariatric surgery | No intervention | Obese men with associated co-morbidities selected for bariatric surgery by multidisciplinary team Receives: Other: Blood and sperm samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of total spermatozoids (NTS) variation
Comparison before/after surgery
Measured: 6 months after surgery
Secondary outcomes (10)
Number of total spermatozoids (NTS) variation
Comparison before/after surgery
Measured: 1 year after surgery
sperm caracteristics
Comparison before/after surgery
Measured: 6 months and 1 year after surgery
Effect of biological parameters on NTS variation
Comparison before/after surgery and search of correlation
Measured: 6 months and 1 year after surgery
Evaluation of environmental parameters : physical activity
Comparison before/after surgery
Measured: 6 months and 1 year after surgery
Other spermatic parameters : DNA fragmentation
Comparison before/after surgery
Measured: 6 months and 1 year after surgery
Other spermatic parameters : CASA
Comparison before/after surgery
Measured: 6 months and 1 year after surgery
Effect of anthropometric parameters on NTS variation
Comparison before/after surgery and search of correlation
Measured: 6 months and 1 year after surgery
Evaluation of environmental parameters : tobacco consumption
Comparison before/after surgery
Measured: 6 months and 1 year after surgery
Evaluation of environmental parameters : libido
Comparison before/after surgery
Measured: 6 months and 1 year after surgery
Evaluation of environmental parameters : quality of life
Comparison before/after surgery
Measured: 6 months and 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2013 (estimated)
- Study start15 Feb 2013
- Primary completion25 Mar 2016
- Study completion25 Mar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Rachel Levy, MD, Study chair, Jean Verdier Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01842295
- Sponsor's protocol ID
- P110153
- Other IDs
- AOM11193
- Acronym
- BARIASPERM
- Status last verified
- Sep 2025
- First submitted
- 19 Feb 2013
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
di Frega AS, Dale B, Di Matteo L, Wilding M. Secondary male factor infertility after Roux-en-Y gastric bypass for morbid obesity: case report. Hum Reprod. 2005 Apr;20(4):997-8. doi: 10.1093/humrep/deh707. Epub 2004 Dec 23.
PubMed 15618249MacDonald AA, Herbison GP, Showell M, Farquhar CM. The impact of body mass index on semen parameters and reproductive hormones in human males: a systematic review with meta-analysis. Hum Reprod Update. 2010 May-Jun;16(3):293-311. doi: 10.1093/humupd/dmp047. Epub 2009 Nov 4.
PubMed 19889752Sermondade N, Massin N, Boitrelle F, Pfeffer J, Eustache F, Sifer C, Czernichow S, Levy R. Sperm parameters and male fertility after bariatric surgery: three case series. Reprod Biomed Online. 2012 Feb;24(2):206-10. doi: 10.1016/j.rbmo.2011.10.014. Epub 2011 Nov 3.
PubMed 22196889Carette C, Levy R, Eustache F, Baron G, Coupaye M, Msika S, Barrat C, Cohen R, Catheline JM, Brugnon F, Slim K, Barsamian C, Chevallier JM, Bretault M, Bouillot JL, Antignac JP, Rives-Lange C, Ravaud P, Czernichow S. Changes in total sperm count after gastric bypass and sleeve gastrectomy: the BARIASPERM prospective study. Surg Obes Relat Dis. 2019 Aug;15(8):1271-1279. doi: 10.1016/j.soard.2019.04.019. Epub 2019 Apr 25.
PubMed 31147284Mifsud F, Czernichow S, Carette C, Levy R, Ravaud P, Cynober L, Neveux N, Rives-Lange C; Bariasperm Study Group. Behaviour of plasma citrulline after bariatric surgery in the BARIASPERM cohort. Clin Nutr. 2021 Feb;40(2):505-510. doi: 10.1016/j.clnu.2020.05.045. Epub 2020 Jun 12.
PubMed 32891457
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bariatric Surgery, Nutrition, and Sperm Quality of Adult Obese Men on Childbearing Age : A Multicentric Cohort Study
- ClinicalTrials.gov ID
- NCT01842295
- Acronym / sponsor ID
- BARIASPERM / P110153
- Conditions
- Obesity, Bariatric Surgery
- Keywords
- Obesity, Bariatric surgery, Sperm quality, Fertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 15 Feb 2013 (actual)
- Primary completion
- 25 Mar 2016 (actual)
- Study completion
- 25 Mar 2016 (actual)
- First posted
- 29 Apr 2013 (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.
The purpose of this study is to evaluate the impact of a bariatric surgery (gastric banding, bypass, sleeve gastrectomy) on several parameters (quality of sperm and others biological parameters, lifestyle, quality of life) involved in fertility of obese adult men.
Detailed description
In order to assess how bariatric surgery may influence their fertility parameters, patients will attend to 3 visits :
First visit (inclusion, before surgery) :
- Signature of consent
- Patient interview (Collection of data on background, treatments, socio-demographic characteristics, social and familial environment, food consumption and habits, tobacco and alcohol use, physical activity, libido and quality of life (surveys))
- Clinical examination and anthropometric assessment (BMI, blood pressure, expired CO)
- Blood samples (Metabolic and nutritional plasmatic biomarkers ; Plasmatic oxidative stress biomarkers ; antioxidants micronutrients ; hormones of adiposity and inflammation ; sex hormones ; persistent contaminants)
- Sperm sample (sperm count-morphology ; DNA fragmentation ; CASA)
Bariatric surgery
Second visit (6 month follow-up)
- Report of adverse events if any
- Surveys
- Blood and sperm samples
Third visit (12 month follow-up)
- Report of adverse events if any
- Blood and sperm samples
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bariatric surgery | No intervention | Other: Blood and sperm samplesObese men with associated co-morbidities selected for bariatric surgery by multidisciplinary team |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Obese men with BMI ≥ 40kg/m² or 35 kg/m² with associated co-morbidities
- Selected for bariatric surgery by multidisciplinary team
- From 18 to 50 years old included
- With a first medical consultation and its results
- With their written informed consent to participate in the study
Key exclusion criteria (2 listed)
- Not candidates for surgery
- With non idiopathic alteration of spermatogenesis
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 samplesBlood and sperm samples will be done in each visit | Other | Bariatric surgery |
Primary outcome
Number of total spermatozoids (NTS) variation
Time frame: 6 months after surgery
Comparison before/after surgery
10 secondary outcomes
Number of total spermatozoids (NTS) variation
Time frame: 1 year after surgery
sperm caracteristics
Time frame: 6 months and 1 year after surgery
Effect of biological parameters on NTS variation
Time frame: 6 months and 1 year after surgery
Evaluation of environmental parameters : physical activity
Time frame: 6 months and 1 year after surgery
Other spermatic parameters : DNA fragmentation
Time frame: 6 months and 1 year after surgery
Other spermatic parameters : CASA
Time frame: 6 months and 1 year after surgery
Effect of anthropometric parameters on NTS variation
Time frame: 6 months and 1 year after surgery
Evaluation of environmental parameters : tobacco consumption
Time frame: 6 months and 1 year after surgery
Evaluation of environmental parameters : libido
Time frame: 6 months and 1 year after surgery
Evaluation of environmental parameters : quality of life
Time frame: 6 months and 1 year after surgery
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 11 Sep 2025.
- Background: PubMed 15618249di Frega AS, Dale B, Di Matteo L, Wilding M. Secondary male factor infertility after Roux-en-Y gastric bypass for morbid obesity: case report. Hum Reprod. 2005 Apr;20(4):997-8. doi: 10.1093/humrep/deh707. Epub 2004 Dec 23.
- Background: PubMed 19889752MacDonald AA, Herbison GP, Showell M, Farquhar CM. The impact of body mass index on semen parameters and reproductive hormones in human males: a systematic review with meta-analysis. Hum Reprod Update. 2010 May-Jun;16(3):293-311. doi: 10.1093/humupd/dmp047. Epub 2009 Nov 4.
- Background: PubMed 22196889Sermondade N, Massin N, Boitrelle F, Pfeffer J, Eustache F, Sifer C, Czernichow S, Levy R. Sperm parameters and male fertility after bariatric surgery: three case series. Reprod Biomed Online. 2012 Feb;24(2):206-10. doi: 10.1016/j.rbmo.2011.10.014. Epub 2011 Nov 3.
- Results publication: PubMed 31147284Carette C, Levy R, Eustache F, Baron G, Coupaye M, Msika S, Barrat C, Cohen R, Catheline JM, Brugnon F, Slim K, Barsamian C, Chevallier JM, Bretault M, Bouillot JL, Antignac JP, Rives-Lange C, Ravaud P, Czernichow S. Changes in total sperm count after gastric bypass and sleeve gastrectomy: the BARIASPERM prospective study. Surg Obes Relat Dis. 2019 Aug;15(8):1271-1279. doi: 10.1016/j.soard.2019.04.019. Epub 2019 Apr 25.
- Results publication: PubMed 32891457Mifsud F, Czernichow S, Carette C, Levy R, Ravaud P, Cynober L, Neveux N, Rives-Lange C; Bariasperm Study Group. Behaviour of plasma citrulline after bariatric surgery in the BARIASPERM cohort. Clin Nutr. 2021 Feb;40(2):505-510. doi: 10.1016/j.clnu.2020.05.045. Epub 2020 Jun 12.
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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.
Rachel Levy, MD study chair
Jean Verdier Hospital
1 site 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 Obesity and Bariatric Surgery, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 7 inclusion and 2 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 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of total spermatozoids (NTS) variation (time frame: 6 months after surgery). 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 NCT01842295, which also lists 5 linked publications.
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 11 Sep 2025.