RecruitingNCT05473273

Descriptive Analysis of Serum Immunological Markers During an Euploid Frozen Embryo Transfer in a Natural Cycle.

Descriptive Analysis of Serum Immunological Markers During an Euploid Frozen Embryo Transfer in a Natural Cycle (NC).


Sponsor

ART Fertility Clinics LLC

Enrollment

40 participants

Start Date

Apr 24, 2023

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 40 Years

Inclusion Criteria4

  • 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 Criteria12

  • 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

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Interventions

DRUGEndometrin 100Mg Vaginal Insert

Endometrin will start once endometrial thickness is equal or higher to 7 mm with a trilaminar appearance, after at least 10 days and always less than 16 days of estradiol administration. First day of supplementation a dose of 100mg will be administered at of at 1.pm and 9 pm. From the second day and onwards administration will be increased to three times daily, at 6 am, 2 pm and 10 pm

DRUGEstradiol Valerate

Estradiol valerate dose will be reduced to 4mg daily at 7 pm during the first two days of vaginal natural micronized progesterone supplementation and increased afterwards to 6 mg daily (2 mg at 10 am and 4 mg at 7 pm).


Locations(1)

ART Fertility Clinics LLC

Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates

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NCT05473273


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