Cohort Study Investigating the Association Between Antichlamydial Antibody Positivity and ART Outcomes in Women With TFI
- Conditions
- Antichlamydial AntibodiesInfertilityChlamydia Trachomatis InfectionTubal Factor Infertility
- Interventions
- Diagnostic Test: antichlamydial antibody testDrug: treatment of infertility with ART
- Registration Number
- NCT04139629
- Lead Sponsor
- D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
- Brief 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.
- Detailed Description
At the first day of stimulation blood analyses for immunoglobulin G (IgG), immunoglobulin A (IgA) and immunoglobulin M (IgM) to major chlamydial antigens (anti-C.trachomatis), major outer membrane protein (MOMP) and plasmid-encoded protein (pgp3) will be performed for patients found eligible for the study.
According to the result of chlamydial antibody test (CAT) participants will be divided into two groups: group A - women with at least one of antibodies detected (CAT+); Group B - seronegative subjects (CAT-).
Women of both groups will undergo a conventional ovarian stimulation (COS) with GnRH antagonist and daily gonadotropin administration at the dose of 150-300 international unit (IU).
Retrieved oocytes following fertilization (conventional IVF or ICSI) will be cultured to Day 3-5 in vitro; ultrasound guided single or double embryo transfer will be performed; remaining embryos of eligible quality will be vitrified.
Patients will be followed up to live birth. Frozen/thawed embryo transfers (FET) will be performed until at least one live birth (≥20 weeks of gestation) occurred or all embryos resulting from the mentioned assisted ovarian stimulation were used.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 292
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description antibody positive (CAT+) antichlamydial antibody test patients found positive for one of the assayed antichlamydial antibodies antibody positive (CAT+) treatment of infertility with ART patients found positive for one of the assayed antichlamydial antibodies antibody negative (CAT-) antichlamydial antibody test women with negative antichlamydia antibody test antibody negative (CAT-) treatment of infertility with ART women with negative antichlamydia antibody test
- Primary Outcome Measures
Name Time Method number of oocytes (COCs) 2-4 weeks after after assignment (at oocyte recovery day) obtained during oocyte pick-up (OPU)
- Secondary Outcome Measures
Name Time Method Number/rate of participants with poor or suboptimal response to COS 2-4 weeks after after assignment (at oocyte recovery day) ≤5, 5-9 cumulus-oocyte complexes (COCs) at OPU respectively
Number / rate of best and good quality embryos per transfer 3-5 weeks after after assignment (at ET day) embryo quality assessment according to known classifications
Implantation rate 3-4 weeks after fresh or frozen/thawed ET ratio of the number of intrauterine gestational sac (at 5-6 weeks of gestation) to the number of transferred embryos
Number of low prognostic patients up to 1 week after assignment according to POSEIDON criteria low prognostic patients will be divided to 4 groups
Duration of stimulation 2-4 weeks after assignment total days of COS: from the first gonadotropins administration to ovulation triggering
clinical pregnancy rate 5-6 weeks after starting the stimulation or 3-4 weeks after frozen/thawed ET presence of intrauterine gestational sac at transvaginal ultrasound at 5-6 weeks of gestation or 5-6 weeks after starting the intervention; measured per embryo transfer
Number / rate of mature (MII) oocytes 2-4 weeks after after assignment (at oocyte recovery day) assessment is done only for ICSI cycles
Fertilization rate at day 1 after oocyte recovery number / rate of two-pronuclear zygotes (2PN) on day 1 after fertilization
Trial Locations
- Locations (1)
D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology
🇷🇺Saint Petersburg, Russian Federation