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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorART Fertility Clinics LLC

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Endometrin 100Mg Vaginal Insert

    Drug

    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

  • Estradiol Valerate

    Drug

    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).

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Natural Cycle Protocol0 interventions
Group B: Hormone Replacement Therapy Protocol2 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
1 day
2

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)

Time frame
1 day
3

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)

Time frame
1 day
4

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)

Time frame
1 day

Secondary outcomes

1

Pregnancy rate

Number of patients with a ß-hCG \> 5 IU out of the number of patients who underwent an embryo transfer.

Time frame
10 days
2

Clinical pregnancy rate

Number of patients with an ultrasonographic visible sac out of the number of patients who underwent an embryo transfer

Time frame
5 weeks and 3 days
3

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

Time frame
12 weeks

Other outcomes

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