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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04139629
• Other study ID #: D-19
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 25, 2019
• Est. completion date: October 30, 2021

Study information

• Verified date: August 2021
• Source: D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 292
• Est. completion date: October 30, 2021
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 41 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology	Saint Petersburg

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Live birth rate	at least one live born baby at =20 weeks of gestation; measured per oocyte aspiration, fresh embryo transfer	up to 3 years after assignment
Other	Cumulative live birth rate	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	up to 3 years after assignment
Other	Cost-effectiveness of COS	ratio of total cost of stimulation, FETs to the number of patients with clinical pregnancy	up to 3 years after assignment
Other	Cycle cancellation rate	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);	up to 2 years after assignment
Primary	number of oocytes (COCs)	obtained during oocyte pick-up (OPU)	2-4 weeks after after assignment (at oocyte recovery day)
Secondary	Number of low prognostic patients	according to POSEIDON criteria low prognostic patients will be divided to 4 groups	up to 1 week after assignment
Secondary	Duration of stimulation	total days of COS: from the first gonadotropins administration to ovulation triggering	2-4 weeks after assignment
Secondary	Number/rate of participants with poor or suboptimal response to COS	=5, 5-9 cumulus-oocyte complexes (COCs) at OPU respectively	2-4 weeks after after assignment (at oocyte recovery day)
Secondary	Number / rate of mature (MII) oocytes	assessment is done only for ICSI cycles	2-4 weeks after after assignment (at oocyte recovery day)
Secondary	Fertilization rate	number / rate of two-pronuclear zygotes (2PN) on day 1 after fertilization	at day 1 after oocyte recovery
Secondary	Number / rate of best and good quality embryos per transfer	embryo quality assessment according to known classifications	3-5 weeks after after assignment (at ET day)
Secondary	Implantation rate	ratio of the number of intrauterine gestational sac (at 5-6 weeks of gestation) to the number of transferred embryos	3-4 weeks after fresh or frozen/thawed ET
Secondary	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	5-6 weeks after starting the stimulation or 3-4 weeks after frozen/thawed ET