InfertilityNCT07405879
The Impact of Having a Tattoo on Fertility Treatment Outcome
An observational study of Infertility and Assisted Reproductive Technology Outcomes, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Tattoos are increasingly common among women of reproductive age, yet their potential systemic inflammatory effects and impact on fertility treatment outcomes are unknown. This prospective observational cohort study aims to evaluate whether the presence, size, duration, and ink characteristics of tattoos are associated… Read more about this study
- Who is it for?
- Ages 21 to 40 years, women only
- Conditions the study is for
- Infertility, Assisted Reproductive Technology Outcomes
- How many people
- 328 participants
- Where
- 1 siteCanada
- Study dates
- 10 Feb 2026to 28 Jan 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population consists of women aged 21 to 40 years undergoing in vitro fertilization (IVF) with a planned fresh or frozen blastocyst embryo transfer at a single academic fertility center. Eligible participants must have at least one good-quality blastocyst available for transfer and provide informed consent. Participants are prospectively followed and categorized based on the presence or absence of tattoos at the time of embryo transfer. Pregnancy and obstetric outcomes are assessed through review of medical records over the study follow-up period.
Who may be able to join
- Women aged 21-40 years Undergoing IVF with planned fresh or frozen blastocyst embryo transfer Availability of good-quality blastocyst embryos Willingness to provide informed consent
Who cannot join
- Significant untreated uterine abnormalities
- ≥3 prior failed embryo transfers Hydrosalpinx in situ BMI >40 kg/m² Age >41 years at embryo creation Submucosal fibroids in situ Use of medications affecting implantation (e.g., chronic steroids, metformin)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
MUHC Reproductive Centre
Montreal, Quebec, H2L4S8
Maya Shavit, MD, +14385963979, maya.genel@gmail.com
About this study
Official title: The Impact of Having a Tattoo on Fertility Treatment Outcome: A Prospective Randomized Controlled Trial
Tattoos are increasingly common among women of reproductive age, yet their potential systemic inflammatory effects and impact on fertility treatment outcomes are unknown. This prospective observational cohort study aims to evaluate whether the presence, size, duration, and ink characteristics of tattoos are associated with pregnancy outcomes following embryo transfer in women undergoing in vitro fertilization (IVF).
Read the detailed description
This is a single-center, prospective observational cohort study conducted at the McGill University Health Centre Reproductive Centre. Women undergoing IVF with planned fresh or frozen blastocyst embryo transfer will be enrolled and categorized based on tattoo presence and characteristics. Tattoo information will be collected using a standardized questionnaire and direct measurement. Participants will be followed for pregnancy and obstetric outcomes through medical chart review. The primary outcome is ongoing pregnancy rate following embryo transfer. Secondary outcomes include clinical pregnancy, biochemical pregnancy, miscarriage, ectopic pregnancy, and live birth.
- Keywords
- In vitro fertilization, Embryo transfer, Live birth, pregnancy, Assisted reproductive technology, Tattoos, Chronic inflammation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Tattoo Group | Participants undergoing IVF with planned embryo transfer who have one or more tattoos at the time of embryo transfer. | |
| No Tattoo Group | Participants undergoing IVF with planned embryo transfer who do not have any tattoos at the time of embryo transfer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing Pregnancy Rate
Presence of fetal heartbeat on ultrasound at ≥12 weeks
Measured: 12 weeks gestation
Secondary outcomes (5)
Clinical pregnancy rate
presence of a gestational sac
Measured: 6-8 weeks of gestation
Biochemical pregnancy
positive BHCG test
Measured: 4-5 weeks of gestation
Miscarriage rate
The spontaneous loss of a fetus
Measured: before the 20th week of pregnancy
Ectopic pregnancy rate
the frequency at which a fertilized egg implants outside the uterine cavity
Measured: upto 10 weeks of gestation
Live birth rate
the frequency of successful deliveries resulting in at least one live-born infant
Measured: over 23 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start10 Feb 2026 (estimated)
- Primary completion28 Jan 2031 (estimated)
- Study completion28 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 328 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Dahan, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- michael haim dahan, MD, Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405879
- Sponsor's protocol ID
- 2026-11525
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves sensitive reproductive health information, and participants did not provide consent for public data sharing. In addition, the study is a single-center observational cohort, and data are retained in coded form in accordance with institutional ethics approval and privacy regulations.
Publications
Xie J, Yan L, Cheng Z, Qiang L, Yan J, Liu Y, Liang R, Zhang J, Li Z, Zhuang L, Hao C, Wang B, Lu Q. Potential effect of inflammation on the failure risk of in vitro fertilization and embryo transfer among infertile women. Hum Fertil (Camb). 2020 Sep;23(3):214-222. doi: 10.1080/14647273.2018.1543898. Epub 2018 Nov 27.
PubMed 30477363Mukherjee N, Sharma R, Modi D. Immune alterations in recurrent implantation failure. Am J Reprod Immunol. 2023 Feb;89(2):e13563. doi: 10.1111/aji.13563. Epub 2022 May 29.
PubMed 35587052Islam PS, Chang C, Selmi C, Generali E, Huntley A, Teuber SS, Gershwin ME. Medical Complications of Tattoos: A Comprehensive Review. Clin Rev Allergy Immunol. 2016 Apr;50(2):273-86. doi: 10.1007/s12016-016-8532-0.
PubMed 26940693
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Having a Tattoo on Fertility Treatment Outcome: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07405879
- Acronym / sponsor ID
- 2026-11525
- Keywords
- In vitro fertilization, Embryo transfer, Live birth, pregnancy, Assisted reproductive technology, Tattoos, Chronic inflammation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 328 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 10 Feb 2026 (estimated)
- Primary completion
- 28 Jan 2031 (estimated)
- Study completion
- 28 Jan 2031 (estimated)
- First posted
- 12 Feb 2026 (actual)
- 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.
Tattoos are increasingly common among women of reproductive age, yet their potential systemic inflammatory effects and impact on fertility treatment outcomes are unknown. This prospective observational cohort study aims to evaluate whether the presence, size, duration, and ink characteristics of tattoos are associated with pregnancy outcomes following embryo transfer in women undergoing in vitro fertilization (IVF).
Detailed description
This is a single-center, prospective observational cohort study conducted at the McGill University Health Centre Reproductive Centre. Women undergoing IVF with planned fresh or frozen blastocyst embryo transfer will be enrolled and categorized based on tattoo presence and characteristics. Tattoo information will be collected using a standardized questionnaire and direct measurement. Participants will be followed for pregnancy and obstetric outcomes through medical chart review. The primary outcome is ongoing pregnancy rate following embryo transfer. Secondary outcomes include clinical pregnancy, biochemical pregnancy, miscarriage, ectopic pregnancy, and live birth.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tattoo Group | – | –Participants undergoing IVF with planned embryo transfer who have one or more tattoos at the time of embryo transfer. |
| No Tattoo Group | – | –Participants undergoing IVF with planned embryo transfer who do not have any tattoos at the time of embryo transfer. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consists of women aged 21 to 40 years undergoing in vitro fertilization (IVF) with a planned fresh or frozen blastocyst embryo transfer at a single academic fertility center. Eligible participants must have at least one good-quality blastocyst available for transfer and provide informed consent. Participants are prospectively followed and categorized based on the presence or absence of tattoos at the time of embryo transfer. Pregnancy and obstetric outcomes are assessed through review of medical records over the study follow-up period.
Key inclusion criteria (1 listed)
- Women aged 21-40 years Undergoing IVF with planned fresh or frozen blastocyst embryo transfer Availability of good-quality blastocyst embryos Willingness to provide informed consent
Key exclusion criteria (2 listed)
- Significant untreated uterine abnormalities
- ≥3 prior failed embryo transfers Hydrosalpinx in situ BMI >40 kg/m² Age >41 years at embryo creation Submucosal fibroids in situ Use of medications affecting implantation (e.g., chronic steroids, metformin)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ongoing Pregnancy Rate
Time frame: 12 weeks gestation
Presence of fetal heartbeat on ultrasound at ≥12 weeks
5 secondary outcomes
Clinical pregnancy rate
Time frame: 6-8 weeks of gestation
Biochemical pregnancy
Time frame: 4-5 weeks of gestation
Miscarriage rate
Time frame: before the 20th week of pregnancy
Ectopic pregnancy rate
Time frame: upto 10 weeks of gestation
Live birth rate
Time frame: over 23 weeks of gestation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 30477363Xie J, Yan L, Cheng Z, Qiang L, Yan J, Liu Y, Liang R, Zhang J, Li Z, Zhuang L, Hao C, Wang B, Lu Q. Potential effect of inflammation on the failure risk of in vitro fertilization and embryo transfer among infertile women. Hum Fertil (Camb). 2020 Sep;23(3):214-222. doi: 10.1080/14647273.2018.1543898. Epub 2018 Nov 27.
- Background: PubMed 35587052Mukherjee N, Sharma R, Modi D. Immune alterations in recurrent implantation failure. Am J Reprod Immunol. 2023 Feb;89(2):e13563. doi: 10.1111/aji.13563. Epub 2022 May 29.
- Background: PubMed 26940693Islam PS, Chang C, Selmi C, Generali E, Huntley A, Teuber SS, Gershwin ME. Medical Complications of Tattoos: A Comprehensive Review. Clin Rev Allergy Immunol. 2016 Apr;50(2):273-86. doi: 10.1007/s12016-016-8532-0.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves sensitive reproductive health information, and participants did not provide consent for public data sharing. In addition, the study is a single-center observational cohort, and data are retained in coded form in accordance with institutional ethics approval and privacy regulations.
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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.
michael haim dahan, MD principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Assisted Reproductive Technology Outcomes, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 1 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: opening soon, as of the sponsor's last update on 12 Feb 2026. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact michael haim dahan, MD (+14389907707, thedoctormichaeldahan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ongoing Pregnancy Rate (time frame: 12 weeks gestation). 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 NCT07405879, which also lists 3 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 12 Feb 2026.