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

NCT04139629 | Unknown

• 1 other identifier: D-19
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Antichlamydial antibodies; in vitro fertilization; ovarian stimulation; tubal factor infertility

Outcome Measures

Primary Outcomes (1)

• number of oocytes (COCs)

  obtained during oocyte pick-up (OPU)

  2-4 weeks after after assignment (at oocyte recovery day)

Secondary Outcomes (8)

• Number of low prognostic patients

  up to 1 week after assignment

• Duration of stimulation

  2-4 weeks after assignment

• Number/rate of participants with poor or suboptimal response to COS

  2-4 weeks after after assignment (at oocyte recovery day)

• Number / rate of mature (MII) oocytes

  2-4 weeks after after assignment (at oocyte recovery day)

• Fertilization rate

  at day 1 after oocyte recovery

Other Outcomes (4)

• Live birth rate

  up to 3 years after assignment

• Cumulative live birth rate

  up to 3 years after assignment

• Cost-effectiveness of COS

  up to 3 years after assignment

Study Arms (2)

antibody positive (CAT+)

OTHER

patients found positive for one of the assayed antichlamydial antibodies

Diagnostic Test: antichlamydial antibody test; Drug: treatment of infertility with ART

antibody negative (CAT-)

OTHER

women with negative antichlamydia antibody test

Diagnostic Test: antichlamydial antibody test; Drug: treatment of infertility with ART

Interventions

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.

antibody negative (CAT-); antibody positive (CAT+)

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.

Also known as: Procedure

antibody negative (CAT-); antibody positive (CAT+)

Eligibility Criteria

• Age: 20 Years - 41 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

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

Saint Petersburg, 199034, Russia

Location

MeSH Terms

Conditions

Infertility

Interventions

Methods

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Alexandr Gzgzyan, Prof, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor at IVF department

Study Record Dates

• First Submitted: October 21, 2019
• First Posted: October 25, 2019
• Study Start: October 25, 2019
• Primary Completion: January 30, 2020
• Study Completion: October 30, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF, CSR
• Time Frame: at the study completion for 1 year
• Access Criteria: 30 random CRFs will be shared, more by request

Locations

RU (1)