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NCT Number: NCT05473273

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

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).

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Key information

Conditions

Infertility, Female Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infertility Long Qt Syndrome 3 Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

ART Fertility Clinics LLC

Abu Dhabi, Abu Dhabi Emirate, 60202, United Arab Emirates

Location status: Recruiting

Location contact

Barbara Lawrenz, PhD

CONTACT

[email protected]

+97102 652 8000

Laura Marqueta Marques

PRINCIPAL_INVESTIGATOR

About this study

This a prospective, observational study including 40 infertile patients undergoing a "single embryo transfer" (SET). Blood samples will be drawn for Progesterone-Induced Blocking Factor (PIBF), interleukin 17 (IL-17), Interferon Gamma (IFγ), Interleukin 10 (IL-10), Interleukin 4 (IL-4) and Transforming Growth Factor beta 1 (TGF-ß1) measurement on the day of ovulation in the natural cycle (NC) or first day of progesterone in the Hormone Replacement Therapy (HRT) protocol, on the day of embryo transfer (ET) and 3 and 10 days later, coinciding with the early and late embryo invasion stages respectively. In case of pregnancy, an additional blood test for PIBF, IL-17, IFγ, IL-10, IL-4, TGF-ß1 and ßHCG (Beta-Human Chorionic Gonadotropin) will be performed at 5 weeks +/- 3 days. The study will be performed at ART Fertility Clinics and the estimated completion time will be 12 months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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)

    Time frame: 1 day

    Blood levels of IL-4 on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)

  2. Blood levels of IL-10 (Interleukin 10) on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)

    Time frame: 1 day

    Blood levels of IL-10 on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)

  3. Blood levels of IL-17 (Interleukin 17) on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)

    Time frame: 1 day

    Blood levels of IL-17 on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)

  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)

    Time frame: 1 day

    Blood levels of TGF-ß1 on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)

  5. Blood levels of IFγ (Interferon gamma) on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)

    Time frame: 1 day

    Blood levels of IFγ on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)

  6. Blood levels of PIBF on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)

    Time frame: 1 day

    Blood levels of PIBF on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)

  7. Blood levels of IL-4 (Interleukin 4) on the day before embryo transfer

    Time frame: 1 day

    Blood levels of IL-4 on the day before embryo transfer

  8. Blood levels of IL-10 (Interleukin 10) on the day before embryo transfer

    Time frame: 1 day

    Blood levels of IL-10 on the day before embryo transfer

  9. Blood levels of IL-17 (Interleukin 17) on the day before embryo transfer

    Time frame: 1 day

    Blood levels of IL-17 on the day before embryo transfer

  10. Blood levels of TGF-ß1 (Transforming Growth Factor beta1) on the day before embryo transfer

    Time frame: 1 day

    Blood levels of TGF-ß1 on the day before embryo transfer

  11. Blood levels of IFγ (Interferon gamma) on the day before embryo transfer

    Time frame: 1 day

    Blood levels of IFγ on the day before embryo transfer

  12. Blood levels of PIBF (Progesterone induced blocking factor) on the day before embryo transfer

    Time frame: 1 day

    Blood levels of PIBF on the day before embryo transfer

  13. Blood levels of IL-4 (Interleukin 4) on the day of embryo transfer

    Time frame: 1 day

    Blood levels of IL-4 on the day of embryo transfer

  14. Blood levels of IL-10 (Interleukin 10) on the day of embryo transfer

    Time frame: 1 day

    Blood levels of IL-10 on the day of embryo transfer

  15. Blood levels of IL-17 (Interleukin 17) on the day of embryo transfer

    Time frame: 1 day

    Blood levels of IL-17 on the day of embryo transfer

  16. Blood levels of TGF-ß1 (Transforming Growth Factor beta1) on the day of embryo transfer

    Time frame: 1 day

    Blood levels of TGF-ß1 on the day of embryo transfer

  17. Blood levels of IFγ (Interferon gamma) on the day of embryo transfer

    Time frame: 1 day

    Blood levels of IFγ on the day of embryo transfer

  18. Blood levels of PIBF (Progesterone induced blocking factor) on the day of embryo transfer

    Time frame: 1 day

    Blood levels of PIBF on the day of embryo transfer

  19. Blood levels of IL-4 (Interleukin 4) three days after embryo transfer

    Time frame: 3 days

    Blood levels of IL-4 three days after embryo transfer

  20. Blood levels of IL-10 (Interleukin 10) three days after embryo transfer

    Time frame: 3 days

    Blood levels of IL-10 three days after embryo transfer

  21. Blood levels of IL-17 (Interleukin 17) three days after embryo transfer

    Time frame: 3 days

    Blood levels of IL-17 three days after embryo transfer

  22. Blood levels of TGF-ß1 (Transforming Growth Factor beta1) three days after embryo transfer

    Time frame: 3 days

    Blood levels of TGF-ß1 three days after embryo transfer

  23. Blood levels of IFγ (Interferon gamma) three days after embryo transfer

    Time frame: 3 days

    Blood levels of IFγ three days after embryo transfer

  24. Blood levels of PIBF (Progesterone induced blocking factor) three days after embryo transfer

    Time frame: 3 days

    Blood levels of PIBF three days after embryo transfer

  25. Blood levels of IL-4 (Interleukin 4) ten days after embryo transfer

    Time frame: 10 days

    Blood levels of IL-4 ten days after embryo transfer

  26. Blood levels of IL-10 (Interleukin 10) ten days after embryo transfer

    Time frame: 10 days

    Blood levels of IL-10 ten days after embryo transfer

  27. Blood levels of IL-17 (Interleukin 17) ten days after embryo transfer

    Time frame: 10 days

    Blood levels of IL-17 ten days after embryo transfer

  28. Blood levels of TGF-ß1 (Transforming Growth Factor beta1) ten days after embryo transfer

    Time frame: 10 days

    Blood levels of TGF-ß1 ten days after embryo transfer

  29. Blood levels of IFγ (Interferon gamma) ten days after embryo transfer

    Time frame: 10 days

    Blood levels of IFγ ten days after embryo transfer

  30. Blood levels of PIBF (Progesterone induced blocking factor) ten days after embryo transfer

    Time frame: 10 days

    Blood levels of PIBF ten days after embryo transfer

  31. Blood levels of IL-4 (Interleukin 4) in case of pregnancy at 5 weeks +/- 3 days

    Time frame: 5 weeks

    Blood levels of IL-4 in case of pregnancy at 5 weeks +/- 3 days

  32. Blood levels of IL-10 (Interleukin 10) in case of pregnancy at 5 weeks +/- 3 days

    Time frame: 5 weeks

    Blood levels of IL-10 in case of pregnancy at 5 weeks +/- 3 days

  33. Blood levels of IL-17 (Interleukin 17) in case of pregnancy at 5 weeks +/- 3 days

    Time frame: 5 weeks

    Blood levels of IL-17 in case of pregnancy at 5 weeks +/- 3 days

  34. Blood levels of TGF-ß1 (Transforming Growth Factor beta1) in case of pregnancy at 5 weeks +/- 3 days

    Time frame: 5 weeks

    Blood levels of TGF-ß1 in case of pregnancy at 5 weeks +/- 3 days

  35. Blood levels of IFγ (Interferon gamma) in case of pregnancy at 5 weeks +/- 3 days

    Time frame: 5 weeks

    Blood levels of IFγ in case of pregnancy at 5 weeks +/- 3 days

  36. Blood levels of PIBF (Progesterone induced blocking factor) in case of pregnancy at 5 weeks +/- 3 days

    Time frame: 5 weeks

    Blood levels of PIBF in case of pregnancy at 5 weeks +/- 3 days

  37. Blood levels of estradiol on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)

    Time frame: 1 day

    Blood levels of estradiol on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)

  38. Blood levels of progesterone on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)

    Time frame: 1 day

    Blood levels of progesterone on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)

  39. Blood levels of estradiol on the day before embryo transfer

    Time frame: 1 day

    Blood levels of estradiol on the day before embryo transfer

  40. Blood levels of progesterone on the day before embryo transfer

    Time frame: 1 day

    Blood levels of progesterone on the day before embryo transfer

  41. Blood levels of estradiol on the day of embryo transfer

    Time frame: 1 day

    Blood levels of estradiol on the day of embryo transfer

  42. Blood levels of progesterone on the day of embryo transfer

    Time frame: 1 day

    Blood levels of progesterone on the day of embryo transfer

  43. Blood levels of estradiol three days after embryo transfer

    Time frame: 3 days

    Blood levels of estradiol three days after embryo transfer

  44. Blood levels of progesterone three days after embryo transfer

    Time frame: 3 days

    Blood levels of progesterone three days after embryo transfer

  45. Blood levels of estradiol ten days after embryo transfer

    Time frame: 10 days

    Blood levels of estradiol ten days after embryo transfer

  46. Blood levels of progesterone ten days after embryo transfer

    Time frame: 10 days

    Blood levels of progesterone ten days after embryo transfer

  47. Blood levels of estradiol in case of pregnancy at 5 weeks +/- 3 days

    Time frame: 5 weeks

    Blood levels of estradiol in case of pregnancy at 5 weeks +/- 3 days

  48. Blood levels of progesterone in case of pregnancy at 5 weeks +/- 3 days

    Time frame: 5 weeks

    Blood levels of progesterone in case of pregnancy at 5 weeks +/- 3 days

  49. Blood levels of ß-hCG (Beta-Human Chorionic Gonadotropin) three days after embryo transfer

    Time frame: 3 days

    Blood levels of ß-hCG three days after embryo transfer

  50. Blood levels of ß-hCG (Beta-Human Chorionic Gonadotropin) ten days after embryo transfer

    Time frame: 10 days

    Blood levels of ß-hCG ten days after embryo transfer

  51. Blood levels of ß-hCG (Beta-Human Chorionic Gonadotropin) in case of pregnancy at 5 weeks +/- 3 days

    Time frame: 5 weeks

    Blood levels of ß-hCG in case of pregnancy at 5 weeks +/- 3 days

Secondary outcomes

  1. Pregnancy rate

    Time frame: 10 days

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

  2. Clinical pregnancy rate

    Time frame: 5 weeks and 3 days

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

  3. Miscarriage rate

    Time frame: 12 weeks

    Number of patients with a pregnancy loss out of the number of patients who had a ß-hCG > 5 IU after embryo transfer

Study contacts

Contact information is provided by the study sponsor or research team.

BARBARA LAWRENZ, PhD

CONTACT

[email protected]

97126528000 ext. 1108

SUZAN SAMIR

CONTACT

[email protected]

97126528000

Sponsors and collaborators

Lead sponsor

ART Fertility Clinics LLC

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 25, 2022
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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