NCT04139629

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

Cohort Study Investigating the Association Between Antichlamydial Antibody Positivity and Efficiency of Treatment With Assisted Reproduction Technologies (ART) in Women With Tubal Factor Infertility

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 292 (actual)
• Sponsor: D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology · Academic / Other
• Sex: Female
• Age: 20 Years – 41 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Antichlamydial Antibodies
• Chlamydia Trachomatis Infection
• Infertility
• Tubal Factor Infertility

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	antichlamydial 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.
DRUG	treatment 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.

Timeline

• Start date: 2019-10-25
• Primary completion: 2020-01-30
• Completion: 2021-10-30
• First posted: 2019-10-25
• Last updated: 2021-08-24

Locations

1 site across 1 country: Russia