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

D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology292 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

292

Conditions

Antichlamydial Antibodies Chlamydia Trachomatis Infection Infertility Tubal Factor Infertility

Interventions

antichlamydial antibody testDIAGNOSTIC_TEST

At the first day of stimulation blood analyses for IgG, IgA and IgM (ELISA) 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.

treatment of infertility with ARTDRUG

COS in gonadotropin-releasing hormone (GnRH) antagonist protocol with IVF/ICSI, fresh ET and, if no pregnancy occurred, frozen/thawed ET (for all embryos resulting from this COS) will be performed.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 41 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Saint Petersburg, Russia

Outcomes

Primary Outcomes

number of oocytes (COCs)

obtained during oocyte pick-up (OPU)

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

Secondary Outcomes

Number of low prognostic patients

according to POSEIDON criteria low prognostic patients will be divided to 4 groups

Time frame: up to 1 week after assignment

Duration of stimulation

total days of COS: from the first gonadotropins administration to ovulation triggering

Time frame: 2-4 weeks after assignment

Number/rate of participants with poor or suboptimal response to COS

≤5, 5-9 cumulus-oocyte complexes (COCs) at OPU respectively

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

Number / rate of mature (MII) oocytes

assessment is done only for ICSI cycles

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

Fertilization rate

number / rate of two-pronuclear zygotes (2PN) on day 1 after fertilization

Time frame: at day 1 after oocyte recovery

Number / rate of best and good quality embryos per transfer

embryo quality assessment according to known classifications

Time frame: 3-5 weeks after after assignment (at ET day)

Implantation rate

ratio of the number of intrauterine gestational sac (at 5-6 weeks of gestation) to the number of transferred embryos

Data from ClinicalTrials.gov

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