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

Primary Purpose

Antichlamydial Antibodies, Chlamydia Trachomatis Infection, Infertility

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
antichlamydial antibody test
treatment of infertility with ART
Sponsored by
D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Antichlamydial Antibodies focused on measuring Antichlamydial antibodies, in vitro fertilization, ovarian stimulation, tubal factor infertility

Eligibility Criteria

20 Years - 41 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

antibody positive (CAT+)

antibody negative (CAT-)

Arm Description

patients found positive for one of the assayed antichlamydial antibodies

women with negative antichlamydia antibody test

Outcomes

Primary Outcome Measures

number of oocytes (COCs)
obtained during oocyte pick-up (OPU)

Secondary Outcome Measures

Number of low prognostic patients
according to POSEIDON criteria low prognostic patients will be divided to 4 groups
Duration of stimulation
total days of COS: from the first gonadotropins administration to ovulation triggering
Number/rate of participants with poor or suboptimal response to COS
≤5, 5-9 cumulus-oocyte complexes (COCs) at OPU respectively
Number / rate of mature (MII) oocytes
assessment is done only for ICSI cycles
Fertilization rate
number / rate of two-pronuclear zygotes (2PN) on day 1 after fertilization
Number / rate of best and good quality embryos per transfer
embryo quality assessment according to known classifications
Implantation rate
ratio of the number of intrauterine gestational sac (at 5-6 weeks of gestation) to the number of transferred embryos
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

Full Information

First Posted
October 21, 2019
Last Updated
August 23, 2021
Sponsor
D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
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1. Study Identification

Unique Protocol Identification Number
NCT04139629
Brief Title
Cohort Study Investigating the Association Between Antichlamydial Antibody Positivity and ART Outcomes in Women With TFI
Official Title
Cohort Study Investigating the Association Between Antichlamydial Antibody Positivity and Efficiency of Treatment With Assisted Reproduction Technologies (ART) in Women With Tubal Factor Infertility
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 25, 2019 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
October 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antichlamydial Antibodies, Chlamydia Trachomatis Infection, Infertility, Tubal Factor Infertility
Keywords
Antichlamydial antibodies, in vitro fertilization, ovarian stimulation, tubal factor infertility

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
292 (Actual)

8. Arms, Groups, and Interventions

Arm Title
antibody positive (CAT+)
Arm Type
Other
Arm Description
patients found positive for one of the assayed antichlamydial antibodies
Arm Title
antibody negative (CAT-)
Arm Type
Other
Arm Description
women with negative antichlamydia antibody test
Intervention Type
Diagnostic Test
Intervention Name(s)
antichlamydial antibody test
Intervention Description
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
Drug
Intervention Name(s)
treatment of infertility with ART
Other Intervention Name(s)
Procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
number of oocytes (COCs)
Description
obtained during oocyte pick-up (OPU)
Time Frame
2-4 weeks after after assignment (at oocyte recovery day)
Secondary Outcome Measure Information:
Title
Number of low prognostic patients
Description
according to POSEIDON criteria low prognostic patients will be divided to 4 groups
Time Frame
up to 1 week after assignment
Title
Duration of stimulation
Description
total days of COS: from the first gonadotropins administration to ovulation triggering
Time Frame
2-4 weeks after assignment
Title
Number/rate of participants with poor or suboptimal response to COS
Description
≤5, 5-9 cumulus-oocyte complexes (COCs) at OPU respectively
Time Frame
2-4 weeks after after assignment (at oocyte recovery day)
Title
Number / rate of mature (MII) oocytes
Description
assessment is done only for ICSI cycles
Time Frame
2-4 weeks after after assignment (at oocyte recovery day)
Title
Fertilization rate
Description
number / rate of two-pronuclear zygotes (2PN) on day 1 after fertilization
Time Frame
at day 1 after oocyte recovery
Title
Number / rate of best and good quality embryos per transfer
Description
embryo quality assessment according to known classifications
Time Frame
3-5 weeks after after assignment (at ET day)
Title
Implantation rate
Description
ratio of the number of intrauterine gestational sac (at 5-6 weeks of gestation) to the number of transferred embryos
Time Frame
3-4 weeks after fresh or frozen/thawed ET
Title
clinical pregnancy rate
Description
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
Time Frame
5-6 weeks after starting the stimulation or 3-4 weeks after frozen/thawed ET
Other Pre-specified Outcome Measures:
Title
Live birth rate
Description
at least one live born baby at ≥20 weeks of gestation; measured per oocyte aspiration, fresh embryo transfer
Time Frame
up to 3 years after assignment
Title
Cumulative live birth rate
Description
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
Time Frame
up to 3 years after assignment
Title
Cost-effectiveness of COS
Description
ratio of total cost of stimulation, FETs to the number of patients with clinical pregnancy
Time Frame
up to 3 years after assignment
Title
Cycle cancellation rate
Description
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);
Time Frame
up to 2 years after assignment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
41 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandr Gzgzyan, Prof, PhD
Organizational Affiliation
D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
Official's Role
Principal Investigator
Facility Information:
Facility Name
D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology
City
Saint Petersburg
ZIP/Postal Code
199034
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
at the end of recruitment ICF and brief CRF will be shared. At the study completion - CSR and SAP will be uploaded
IPD Sharing Time Frame
at the study completion for 1 year
IPD Sharing Access Criteria
30 random CRFs will be shared, more by request

Learn more about this trial

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

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