The Impact of Having a Tattoo on Fertility Treatment Outcome

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).

Study Overview

Status

Not yet recruiting

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 Type

Observational

Enrollment (Estimated)

328

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Quebec
      • Montreal, Quebec, Canada, H2L4S8
        • MUHC Reproductive Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ongoing Pregnancy Rate
Time Frame: 12 weeks gestation
Presence of fetal heartbeat on ultrasound at ≥12 weeks
12 weeks gestation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 6-8 weeks of gestation
presence of a gestational sac
6-8 weeks of gestation
Biochemical pregnancy
Time Frame: 4-5 weeks of gestation
positive BHCG test
4-5 weeks of gestation
Miscarriage rate
Time Frame: before the 20th week of pregnancy
The spontaneous loss of a fetus
before the 20th week of pregnancy
Ectopic pregnancy rate
Time Frame: upto 10 weeks of gestation
the frequency at which a fertilized egg implants outside the uterine cavity
upto 10 weeks of gestation
Live birth rate
Time Frame: over 23 weeks of gestation
the frequency of successful deliveries resulting in at least one live-born infant
over 23 weeks of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: michael haim dahan, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 10, 2026

Primary Completion (Estimated)

January 28, 2031

Study Completion (Estimated)

January 28, 2031

Study Registration Dates

First Submitted

February 5, 2026

First Submitted That Met QC Criteria

February 5, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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