CompletedNot Applicable

Uterine Scratching in Intra-Uterine Insemination

Canada394 participantsStarted 2018-07-15

Plain-language summary

This study will evaluate the potential benefits of uterine injury during the follicular phase of an intra-uterine insemination cycle on the rate of ongoing pregnancy during the first trimester ultrasound.

Who can participate

Age range

18 Years – 41 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Unexplained infertility for over 12 months if under 35 years old or over 6 months if 35 years old and above. * At least one permeable tube on hysterosonography or hysterosalpingography within the last 2 years or vaginal delivery in the last 3 years. * Antral follicular count over 5. * Normal or mild male factor. * Normal uterine cavity. * An IUI prescription. Exclusion Criteria: * Polycystic ovary syndrome with irregular menstrual cycles over 45 days * Severe endometriosis * IUI with Donor sperm * Patient with invasive intra-uterine procedure in the last 3 months. * Contraindication to endometrial biopsy.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Efficacy - Pregnancy Rate measured during the first trimester ultrasound.

Timeframe: 13 weeks

Trial details

NCT IDNCT03828786

SponsorClinique Ovo

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03-31

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