Cohort Study Investigating the Association Between Antichlamydial Antibody Positivity and Efficiency of Treatment With Assisted Reproduction Technologies (ART) in Women With Tubal Factor Infertility
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 292
- 试验地点
- 1
- 主要终点
- number of oocytes (COCs)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 41 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
antibody positive (CAT+)
patients found positive for one of the assayed antichlamydial antibodies
干预措施: antichlamydial antibody test (Diagnostic Test)
antibody positive (CAT+)
patients found positive for one of the assayed antichlamydial antibodies
干预措施: treatment of infertility with ART (Drug)
antibody negative (CAT-)
women with negative antichlamydia antibody test
干预措施: antichlamydial antibody test (Diagnostic Test)
antibody negative (CAT-)
women with negative antichlamydia antibody test
干预措施: treatment of infertility with ART (Drug)
结局指标
主要结局
number of oocytes (COCs)
时间窗: 2-4 weeks after after assignment (at oocyte recovery day)
obtained during oocyte pick-up (OPU)
次要结局
- Number/rate of participants with poor or suboptimal response to COS(2-4 weeks after after assignment (at oocyte recovery day))
- Number / rate of best and good quality embryos per transfer(3-5 weeks after after assignment (at ET day))
- Implantation rate(3-4 weeks after fresh or frozen/thawed ET)
- Number of low prognostic patients(up to 1 week after assignment)
- Duration of stimulation(2-4 weeks after assignment)
- clinical pregnancy rate(5-6 weeks after starting the stimulation or 3-4 weeks after frozen/thawed ET)
- Number / rate of mature (MII) oocytes(2-4 weeks after after assignment (at oocyte recovery day))
- Fertilization rate(at day 1 after oocyte recovery)
研究者
Valeria Muller
Doctor at IVF department
D.O. Ott Research Institute of Obstetrics, Gynecology, and Reproductology