About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Infertile women undergoing a single frozen embryo transfer
Trial design
Cohort
Prospective
Treatments tested in this trial
Endometrin 100Mg Vaginal Insert
DrugEndometrin 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
Estradiol Valerate
DrugEstradiol 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).
Treatment groups
Trial outcomes
Primary outcomes
Blood levels of IL-4 (Interleukin 4) on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
Blood levels of IL-4 on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
Blood levels of IL-10 (Interleukin 10) on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
Blood levels of IL-10 on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
Blood levels of IL-17 (Interleukin 17) on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
Blood levels of IL-17 on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
Blood levels of TGF-ß1 (Transforming Growth Factor beta1) on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
Blood levels of TGF-ß1 on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
Secondary outcomes
Pregnancy rate
Number of patients with a ß-hCG \> 5 IU out of the number of patients who underwent an embryo transfer.
Clinical pregnancy rate
Number of patients with an ultrasonographic visible sac out of the number of patients who underwent an embryo transfer
Miscarriage rate
Number of patients with a pregnancy loss out of the number of patients who had a ß-hCG \> 5 IU after embryo transfer
Sponsors and contacts
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