NCT07405879

Brief 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 with pregnancy outcomes following embryo transfer in women undergoing in vitro fertilization (IVF).

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
328

participants targeted

Target at P75+ for all trials

Timeline
58mo left

Started Feb 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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 Progress4%
Feb 2026Jan 2031

First Submitted

Initial submission to the registry

February 5, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

February 10, 2026

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 12, 2026

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2031

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

5 years

First QC Date

February 5, 2026

Last Update Submit

February 5, 2026

Conditions

Keywords

In vitro fertilizationEmbryo transferLive birthpregnancyAssisted reproductive technologyTattoosChronic inflammation

Outcome Measures

Primary Outcomes (1)

  • Ongoing Pregnancy Rate

    Presence of fetal heartbeat on ultrasound at ≥12 weeks

    12 weeks gestation

Secondary Outcomes (5)

  • Clinical pregnancy rate

    6-8 weeks of gestation

  • Biochemical pregnancy

    4-5 weeks of gestation

  • Miscarriage rate

    before the 20th week of pregnancy

  • Ectopic pregnancy rate

    upto 10 weeks of gestation

  • Live birth rate

    over 23 weeks of gestation

Study Arms (2)

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.

Eligibility Criteria

Age21 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MUHC Reproductive Centre

Montreal, Quebec, H2L4S8, Canada

Location

Related Publications (3)

  • 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.

    PMID: 30477363BACKGROUND
  • Mukherjee 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.

    PMID: 35587052BACKGROUND
  • Islam 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.

    PMID: 26940693BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • michael haim dahan, MD

    McGill University Health Centre/Research Institute of the McGill University Health Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

michael haim dahan, MD

CONTACT

maya shavit, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 5, 2026

First Posted

February 12, 2026

Study Start

February 10, 2026

Primary Completion (Estimated)

January 28, 2031

Study Completion (Estimated)

January 28, 2031

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations