Antichlamydial AntibodiesNCT04139629
Cohort Study Investigating the Association Between Antichlamydial Antibody Positivity and ART Outcomes in Women With TFI
A study testing antichlamydial antibody test and treatment of infertility with ART in people with Antichlamydial Antibodies and Chlamydia Trachomatis Infection, run by D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 41 years, women only
- Conditions the study is for
- Antichlamydial Antibodies, Chlamydia Trachomatis Infection, Infertility
- What is being tested?
- antichlamydial antibody test and treatment of infertility with ART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteRussia
- Study dates
- 25 Oct 2019to 30 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 41 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology
Saint Petersburg, 199034
About this study
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
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.
Read the 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
- Being tested
- antichlamydial antibody test, treatment of infertility with ART
- Keywords
- Antichlamydial antibodies, in vitro fertilization, ovarian stimulation, tubal factor infertility
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antichlamydial antibody testDiagnostic 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 ARTDrug
Also called Procedure
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.
| Study group | Role | What they receive |
|---|---|---|
| antibody positive (CAT+) | Other | patients found positive for one of the assayed antichlamydial antibodies Receives: Diagnostic Test: antichlamydial antibody test; Drug: treatment of infertility with ART |
| antibody negative (CAT-) | Other | women with negative antichlamydia antibody test Receives: Diagnostic Test: antichlamydial antibody test; Drug: treatment of infertility with ART |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of oocytes (COCs)
obtained during oocyte pick-up (OPU)
Measured: 2-4 weeks after after assignment (at oocyte recovery day)
Secondary outcomes (8)
Number of low prognostic patients
according to POSEIDON criteria low prognostic patients will be divided to 4 groups
Measured: up to 1 week after assignment
Duration of stimulation
total days of COS: from the first gonadotropins administration to ovulation triggering
Measured: 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
Measured: 2-4 weeks after after assignment (at oocyte recovery day)
Number / rate of mature (MII) oocytes
assessment is done only for ICSI cycles
Measured: 2-4 weeks after after assignment (at oocyte recovery day)
Fertilization rate
number / rate of two-pronuclear zygotes (2PN) on day 1 after fertilization
Measured: at day 1 after oocyte recovery
Number / rate of best and good quality embryos per transfer
embryo quality assessment according to known classifications
Measured: 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
Measured: 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
Measured: 5-6 weeks after starting the stimulation or 3-4 weeks after frozen/thawed ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start25 Oct 2019
- Primary completion30 Jan 2020
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antichlamydial AntibodiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valeria Muller, D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
- Investigators
- Alexandr Gzgzyan, Prof, PhD, Principal investigator, D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139629
- Sponsor's protocol ID
- D-19
- Status last verified
- Aug 2021
- First submitted
- 21 Oct 2019
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: at the end of recruitment ICF and brief CRF will be shared. At the study completion - CSR and SAP will be uploaded
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04139629
- Acronym / sponsor ID
- D-19
- Conditions
- Antichlamydial Antibodies, Chlamydia Trachomatis Infection, Infertility, Tubal Factor Infertility
- Keywords
- Antichlamydial antibodies, in vitro fertilization, ovarian stimulation, tubal factor infertility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 292 participants (actual)
- Lead sponsor
- D.O. Ott Research Institute of Obstetrics, Gynecology, and ReproductologyUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| antibody positive (CAT+) | Other | Diagnostic Test: antichlamydial antibody test, Drug: treatment of infertility with ARTpatients found positive for one of the assayed antichlamydial antibodies |
| antibody negative (CAT-) | Other | Diagnostic Test: antichlamydial antibody test, Drug: treatment of infertility with ARTwomen with negative antichlamydia antibody test |
Who may qualify
- Ages
- 20 to 41 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (10 listed)
- previous ovarian surgery;
- endometriosis;
- antimullerian hormone (AMH) level ≤0,3 ng/ml;
- hyper- or hypogonadotropic ovarian failure;
- severe male factor infertility;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antichlamydial antibody testAt 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. | Diagnostic test | antibody negative (CAT-), antibody positive (CAT+) |
| treatment of infertility with ARTAlso: ProcedureCOS 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. | Drug | antibody negative (CAT-), antibody positive (CAT+) |
Primary outcome
number of oocytes (COCs)
Time frame: 2-4 weeks after after assignment (at oocyte recovery day)
obtained during oocyte pick-up (OPU)
8 secondary outcomes
Number of low prognostic patients
Time frame: up to 1 week after assignment
Duration of stimulation
Time frame: 2-4 weeks after assignment
Number/rate of participants with poor or suboptimal response to COS
Time frame: 2-4 weeks after after assignment (at oocyte recovery day)
Number / rate of mature (MII) oocytes
Time frame: 2-4 weeks after after assignment (at oocyte recovery day)
Fertilization rate
Time frame: at day 1 after oocyte recovery
Number / rate of best and good quality embryos per transfer
Time frame: 3-5 weeks after after assignment (at ET day)
Implantation rate
Time frame: 3-4 weeks after fresh or frozen/thawed ET
clinical pregnancy rate
Time frame: 5-6 weeks after starting the stimulation or 3-4 weeks after frozen/thawed ET
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
- Individual participant dataSharing planned: Yes. at the end of recruitment ICF and brief CRF will be shared. At the study completion - CSR and SAP will be uploaded
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandr Gzgzyan, Prof, PhD principal investigator
D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing antichlamydial antibody test and treatment of infertility with ART in people with Antichlamydial Antibodies and Chlamydia Trachomatis Infection, run by D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of oocytes (COCs) (time frame: 2-4 weeks after after assignment (at oocyte recovery day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2021.