Antichlamydial Antibodies, Chlamydia Trachomatis Infection, Infertility, Tubal Factor Infertility
Conditions
Keywords
Antichlamydial antibodies, in vitro fertilization, ovarian stimulation, tubal factor infertility
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.
Interventions
DIAGNOSTIC_TESTantichlamydial antibody 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.
DRUGtreatment of infertility with ART
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.
Sponsors
D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 41 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of oocytes (COCs) | 2-4 weeks after after assignment (at oocyte recovery day) | obtained during oocyte pick-up (OPU) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Fertilization rate | at day 1 after oocyte recovery | number / rate of two-pronuclear zygotes (2PN) on day 1 after fertilization |
| 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 |
| 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 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 |
| Number / rate of mature (MII) oocytes | 2-4 weeks after after assignment (at oocyte recovery day) | assessment is done only for ICSI cycles |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness of COS | up to 3 years after assignment | ratio of total cost of stimulation, FETs to the number of patients with clinical pregnancy |
| Cycle cancellation rate | up to 2 years after assignment | during COS (no response), at OPU (premature ovulation, absence or degradation of COCs), during in vitro cultivation and thawing (fertilization failure, inadequate embryo quality), other reasons (adverse events, hyper stimulation syndrome, withdrawal); |
| Live birth rate | up to 3 years after assignment | at least one live born baby at ≥20 weeks of gestation; measured per oocyte aspiration, fresh embryo transfer |
| Cumulative live birth rate | up to 3 years after assignment | at least one live born baby at ≥20 weeks of gestation from ART aspiration cycle, including fresh and frozen/thawed ET, resulting from assisted ovarian stimulation until one live birth occurred or all embryos were used |
Countries
Russia
Outcome results
None listed