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NCT05473273
Descriptive Analysis of Serum Immunological Markers During an Euploid Frozen Embryo Transfer in a Natural Cycle.
Conditions: Infertility, Female
Sex: Female
Ages: 18 Years – 40 Years
Healthy volunteers: Yes
Enrollment: 40
Sponsor: ART Fertility Clinics LLC
Location: ART Fertility Clinics LLC Abu Dhabi Abu Dhabi Emirate
Summary
To describe the peripheral serum levels of the anti-inflammatory cytokines IL-4 (Interleukin-4), IL-10 (Interleukin-10), TGF-ß1 (Transforming Growth Factor beta1), the pro-inflammatory cytokines IL-17 (Interleukin-17), IFγ (Interferon Gamma) and the immune mediator PIBF (Progesterone-Induced Blocking Factor) along a single frozen euploid blastocyst transfer in a natural cycle (NC) or Hormone Replacement Therapy (HRT).
Eligibility Criteria
Inclusion Criteria:
* Women aged 18 years to 40 years
* Having at least one good quality (grade A or B for inner mass cell and trophectoderm) day 5 or 6 chromosomally normal cryopreserved blastocyst available for transfer
* Single embryo transfer in a natural cycle (NC) or an Hormone Replacement Therapy (HRT) protocol
* Fresh ejaculate used for fertilization
Exclusion Criteria:
* Body mass index lower than 18.5 or equal or higher than 29 kg/m2
* Endometriosis or adenomyosis suspected by medical history (dysmenorrhea, dyspareunia, heavy or prolonged menstrual bleeding (\> 8 days), chronic pelvic pain, catamenial rectal or bladder symptoms) or diagnosed by imaging (magnetic resonance imaging or ultrasonography)
* Uterine abnormalities
* Hydrosalpinx
* Insulin resistance or diabetes mellitus diagnosed by HbA1c 5.7 %
* Antiphospholipid syndrome
* Polycystic ovarian syndrome according to Rotterdam criteria: presence of at least two of the following: irregular cycles (\< 21 or \> 35 days or \< 8 cycles a year), biochemical or clinical hyperandrogenism, ovarian ultrasound morphology (\> 20 follicles per ovary on transvaginal scan) or Anti-mullerian hormone \> 5,98 ng/ml
* History of recurrent miscarriage, defined as the loss of 2 or more pregnancies according to ESHRE guidelines
* History of implantation failure, considered as the lack of pregnancy after the transfer of 2 good-quality (grade A or B for inner mass cell and trophectoderm (29)) euploid embryos
* History or suspicion of Asherman syndrome
* Autoimmune disease
* Couple first degree consanguineous
Source: ClinicalTrials.gov (NCT05473273). StuddyBuddy aggregates publicly available trial information.