- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07405879
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
Study Overview
Status
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: michael haim dahan, MD
- Phone Number: +14389907707
- Email: thedoctormichaeldahan@gmail.com
Study Contact Backup
- Name: Maya Shavit, MD
- Phone Number: +14385963979
- Email: maya.genel@gmail.com
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H2L4S8
- MUHC Reproductive Centre
-
Contact:
- Maya Shavit, MD
- Phone Number: +14385963979
- Email: maya.genel@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Investigators
- Principal Investigator: michael haim dahan, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-11525
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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