Clinical trial NCT04139629: Cohort Study Investigating the Association Between Antichlamydial Antibody Positivity and ART Outcomes in Women With TFI
Official title: Cohort Study Investigating the Association Between Antichlamydial Antibody Positivity and Efficiency of Treatment With Assisted Reproduction Technologies (ART) in Women With Tubal Factor Infertility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Antichlamydial Antibodies
Chlamydia Trachomatis Infection
Infertility
Tubal Factor Infertility
Keywords: Antichlamydial antibodies
in vitro fertilization
ovarian stimulation
tubal factor infertility
Lead sponsor: D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
Sponsor class: OTHER
First posted: 2019-10-25
Enrollment: 292
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: number of oocytes (COCs)
timeFrame: 2-4 weeks after after assignment (at oocyte recovery day)
Secondary outcomes:
measure: Number of low prognostic patients
timeFrame: up to 1 week after assignment
measure: Duration of stimulation
timeFrame: 2-4 weeks after assignment
measure: Number/rate of participants with poor or suboptimal response to COS
timeFrame: 2-4 weeks after after assignment (at oocyte recovery day)
measure: Number / rate of mature (MII) oocytes
timeFrame: 2-4 weeks after after assignment (at oocyte recovery day)
measure: Fertilization rate
timeFrame: at day 1 after oocyte recovery
measure: Number / rate of best and good quality embryos per transfer
timeFrame: 3-5 weeks after after assignment (at ET day)
measure: Implantation rate
timeFrame: 3-4 weeks after fresh or frozen/thawed ET
measure: clinical pregnancy rate
timeFrame: 5-6 weeks after starting the stimulation or 3-4 weeks after frozen/thawed ET
Other outcomes:
measure: Live birth rate
timeFrame: up to 3 years after assignment
measure: Cumulative live birth rate
timeFrame: up to 3 years after assignment
measure: Cost-effectiveness of COS
timeFrame: up to 3 years after assignment
measure: Cycle cancellation rate
timeFrame: up to 2 years after assignment
Locations:
city: Saint Petersburg
country: Russian Federation
facility: D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology
Study officials:
affiliation: D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
name: Alexandr Gzgzyan, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
References: