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

NCT ID: NCT04139629

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-25
• Study Completion Date: 2021-10-30

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

antibody positive (CAT+)

patients found positive for one of the assayed antichlamydial antibodies

Group Type: OTHER

antichlamydial antibody test

Intervention Type: 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.

treatment of infertility with ART

Intervention Type: 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.

antibody negative (CAT-)

women with negative antichlamydia antibody test

Group Type: OTHER

antichlamydial antibody test

Intervention Type: 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.

treatment of infertility with ART

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: DRUG

Other Intervention Names

Procedure

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 41 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Valeria Muller

Doctor at IVF department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alexandr Gzgzyan, Prof, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

D-19

Identifier Type: -

Identifier Source: org_study_id