Cohort Study Investigating the Association Between Antichlamydial Antibody Positivity and ART Out… (NCT04139629) | Clinical Trial Compass
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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 range20 Years – 41 Years
SexFEMALE
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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.
What they're measuring
1
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