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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| antibody positive (CAT+) | Other | patients found positive for one of the assayed antichlamydial antibodies |
|
| antibody negative (CAT-) | Other | women with negative antichlamydia antibody test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| antichlamydial antibody test | Diagnostic 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. |
| Measure | Description | Time Frame |
|---|---|---|
| number of oocytes (COCs) | obtained during oocyte pick-up (OPU) | 2-4 weeks after after assignment (at oocyte recovery day) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of low prognostic patients | according to POSEIDON criteria low prognostic patients will be divided to 4 groups | up to 1 week after assignment |
| Duration of stimulation | total days of COS: from the first gonadotropins administration to ovulation triggering |
| Measure | Description | Time Frame |
|---|---|---|
| Live birth rate | at least one live born baby at ≥20 weeks of gestation; measured per oocyte aspiration, fresh embryo transfer | up to 3 years after assignment |
| Cumulative live birth rate | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandr Gzgzyan, Prof, PhD | D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology | Saint Petersburg | 199034 | Russia |
at the end of recruitment ICF and brief CRF will be shared. At the study completion - CSR and SAP will be uploaded
at the study completion for 1 year
30 random CRFs will be shared, more by request
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|
| treatment of infertility with ART | Drug | 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. |
|
|
| 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 | 2-4 weeks after after assignment (at oocyte recovery day) |
| Number / rate of mature (MII) oocytes | assessment is done only for ICSI cycles | 2-4 weeks after after assignment (at oocyte recovery day) |
| Fertilization rate | number / rate of two-pronuclear zygotes (2PN) on day 1 after fertilization | at day 1 after oocyte recovery |
| Number / rate of best and good quality embryos per transfer | embryo quality assessment according to known classifications | 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 | 3-4 weeks after fresh or frozen/thawed ET |
| clinical pregnancy rate | 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 | 5-6 weeks after starting the stimulation or 3-4 weeks after frozen/thawed ET |
| up to 3 years after assignment |
| Cost-effectiveness of COS | ratio of total cost of stimulation, FETs to the number of patients with clinical pregnancy | up to 3 years after assignment |
| Cycle cancellation rate | 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); | up to 2 years after assignment |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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