UnknownNot Applicable

Cohort Study Investigating the Association Between Antichlamydial Antibody Positivity and ART Outcomes in Women With TFI

Russia292 participantsStarted 2019-10-25

Plain-language summary

In a prospective cohort study investigators will examine characteristics and clinical outcomes of treatment with ART in women with tubal factor infertility (TFI) with regard to seropositivity to antichlamydial antibodies.

Who can participate

Age range

20 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: * Tubal factor infertility diagnosed by laparoscopy; * Female age between 20-41 years; * BMI 17,5-35 kg/m2; * Early follicular phase follicle stimulating hormone (FSH) ≤15 IU/L * Presence of viable spermatozoa in partner's sperm; * Signed informed consent. Exclusion Criteria: * previous ovarian surgery; * endometriosis; * antimullerian hormone (AMH) level ≤0,3 ng/ml; * hyper- or hypogonadotropic ovarian failure; * severe male factor infertility; * Pre-existing medical condition preventing or interfering with IVF treatment: any clinically significant systemic disease; inherited or acquires thrombophilia and thromboembolism; endocrine or metabolic abnormalities; moderate or severe impairment of renal or hepatic function; any oncological diseases in anamnesis; known history of recurrent miscarriage, abnormal karyotype of both partners; currently active pelvic inflammatory disease; * Abnormal IVF screening tests: Papanicolaou (PAP) smear, Syphilis, HIV 1\&2, Hepatitis B, Hepatitis C, Chlamydia, and Gonorrhea; * Presence of uterine pathology: Asherman's Syndrome, endometrial polyps, nodus form of adenomyosis or uterine fibroids ≥3 mm in diameter; * Visualization of ovarian cysts ≥25 mm, endometriomas or hydrosalpinx; * One or more follicles ≥8 mm at the start of the COS protocol.

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

number of oocytes (COCs)

Timeframe: 2-4 weeks after after assignment (at oocyte recovery day)

Trial details

NCT IDNCT04139629

SponsorD.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-30

View on ClinicalTrials.gov More Antichlamydial Antibodies trials