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Uterine Scratching for Infertility
N/A
Waitlist Available
Led By Louise Lapensee, Md
Research Sponsored by Clinique Ovo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
An IUI prescription
Unexplained infertility for over 12 months if under 35 years old or over 6 months if 35 years old and above.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months for all 3 intrauterine insemination
Awards & highlights
Study Summary
This trial will test if uterine injury during the follicular phase of an intra-uterine insemination cycle helps with pregnancy rates during the first trimester ultrasound.
Who is the study for?
This trial is for people under 35 with unexplained infertility for over a year, or over 6 months if they're 35+. They must have at least one open fallopian tube and a normal uterine cavity. Men should have normal or mildly affected fertility. Those who've had invasive uterine procedures recently, severe endometriosis, irregular cycles due to PCOS, or need donor sperm can't join.Check my eligibility
What is being tested?
The study tests whether 'uterine scratching' (a minor injury to the uterus lining) during the follicular phase helps increase ongoing pregnancy rates in the first trimester after intra-uterine insemination (IUI).See study design
What are the potential side effects?
Uterine scratching may cause discomfort, cramping, bleeding similar to menstrual periods, and there's a small risk of infection following the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a prescription for intrauterine insemination (IUI).
Select...
I have been unable to conceive for over a year if under 35, or over 6 months if 35 or older.
Select...
I have been unable to conceive for over a year if under 35, or over 6 months if 35 or older.
Select...
My uterine cavity is normal.
Select...
My uterine cavity is normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months for all 3 intrauterine insemination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months for all 3 intrauterine insemination
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy - Pregnancy Rate measured during the first trimester ultrasound.
Secondary outcome measures
Efficacy - Secondary pregnancy rate.
Safety - Complications
Safety - Side effects
Trial Design
2Treatment groups
Active Control
Group I: Endometrial scratching groupActive Control1 Intervention
Endometrial scratching will be done with a Pipelle in uterus.
Group II: Control groupActive Control1 Intervention
This group will proceed with intrauterine insemination without endometrial scratching according to clinic's standard procedure
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Who is running the clinical trial?
Clinique OvoLead Sponsor
31 Previous Clinical Trials
41,113 Total Patients Enrolled
Louise Lapensee, MdPrincipal InvestigatorClinique Ovo
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a prescription for intrauterine insemination (IUI).I have been unable to conceive for over a year if under 35, or over 6 months if 35 or older.I have PCOS and my periods are often more than 45 days apart.I cannot have an endometrial biopsy due to health reasons.I have severe endometriosis.I've had a successful pregnancy or a test showing open fallopian tubes in the last 2-3 years.I have been unable to conceive for over a year if under 35, or over 6 months if 35 or older.My uterine cavity is normal.I have a prescription for intrauterine insemination (IUI).My uterine cavity is normal.I've had a successful pregnancy or a test showing open fallopian tubes in the last 2-3 years.
Research Study Groups:
This trial has the following groups:- Group 1: Endometrial scratching group
- Group 2: Control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
For whom is this research opportunity available?
"Aspiring participants of this clinical trial must satisfy two criteria: they need to fall between the ages 18-41 and be diagnosed with infertility. All in all, 394 individuals are needed for recruitment."
Answered by AI
Who else is applying?
What state do they live in?
Georgia
Nevada
What site did they apply to?
Clinique Ovo
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2
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