RecruitingNCT05473273Updated Jun 25, 2026

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

An observational study in Infertility, Female, sponsored by ART Fertility Clinics LLC. Recruiting at 1 site in United Arab Emirates. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by ART Fertility Clinics LLC · Observational

From the registry’s dates

Started Apr 2023; still recruiting 3 years 6 months later.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 40
Ages: 18 Years to 40 Years
Sex: Female

Study 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).

Read the detailed description

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.

Conditions studied

Infertility, Female

Browse trials for

Infertility, Female 552

Keywords

infertilty
ivf
progesterone
estradiol
cytokines
immunology
Pharmacological effect of drugs
hormones

In context

Infertility, Female

552 studies on the registry are indexed under Infertility, Female; 137 are open to participants now.

This study's planned enrollment of 40 is below the median of 161 across 162 observational studies indexed under Infertility, Female.

Browse Infertility, Female studies →

Lead sponsor

ART Fertility Clinics LLC is the lead sponsor of 51 studies on the registry; 20 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 40 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

Infertile women undergoing a single frozen embryo transfer

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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 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
disease
Couple first degree consanguineous

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 40 participants (estimated)
Patient registry: No
Biospecimen retention: Samples with dna

Groups and cohorts

Natural Cycle Protocol
Ultrasound monitoring to monitor follicular and endometrial growth. Serial measurements of serum Lutenizing Hormone (LH), estradiol (E2), and progesterone (P4) to identify ovulation. Minimal endometrial thickness of 7 mm is required. No progesterone supplementation. Embryo transfer (ET) will be scheduled 5 days after the day of ovulation (120 hours of P4 exposure). Blood samples will be drawn to measure PIBF, IL-17, IFγ, IL-10, IL-4 and TGF-ß1 on day of ovulation (P4 rise), on the day before ET, on the day of ET and 3 and 10 days later, between 9 and 12 am. A blood test to measure beta human chorionic gonadotropin (ß-hCG) will be performed 3 and 10 days after ET and at 5 weeks +/- 3 days in case of pregnancy, between 9 and 12 am. In case of pregnancy, a blood test to measure PIBF, IL-17, IFγ, IL-10, IL-4 and TGF-ß1 will be performed at 5 weeks +/- 3 days between 9 and 12 am..
Hormone Replacement Therapy Protocol
Ultrasound monitoring of endometrial growth and exclude growing follicle Oral Estradiol Valerate (Progyluton) 4 mg on cycle day 2 at 7 pm for 2 days. On 3rd day, increase dose to 6 mg. The dose may be increased based on endometrial thickness. Once endometrial thickness is at least 7 mm and trilaminar, after 10-15 days of Estradiol Valerate administration, start Endometrin 100 mg at 1 pm and 9 pm. From 2nd day onwards increase to 3 times daily. Continue Progyluton \& Endometrin until 12 weeks of pregnancy ET on the 5th full day of Endometrin administration Blood test to measure PIBF, IL-17, IFγ, IL-4, IL-10 and TGF-ß1 on the 1st day of Endometrin supplementation (before 1st administration), on the 4th day of Endometrin administration, on the day of ET and 3 and10 days after, 4 to 7 hours after the morning administration. Blood test to measure beta human chorionic gonadotropin (ß-hCG) will be performed 3 and 10 days after ET and at 5 weeks +/- 3 days if pregnancy.
Drug: Endometrin 100Mg Vaginal Insert · Drug: Estradiol Valerate

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).

What researchers measure

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)
Time frame: 1 day
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
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
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
Blood levels of IFγ (Interferon gamma) on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
Blood levels of IFγ 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)
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 IL-4 (Interleukin 4) on the day before embryo transfer
Blood levels of IL-4 on the day before embryo transfer
Time frame: 1 day
Blood levels of IL-10 (Interleukin 10) on the day before embryo transfer
Blood levels of IL-10 on the day before embryo transfer
Time frame: 1 day
Blood levels of IL-17 (Interleukin 17) on the day before embryo transfer
Blood levels of IL-17 on the day before embryo transfer
Time frame: 1 day
Blood levels of TGF-ß1 (Transforming Growth Factor beta1) on the day before embryo transfer
Blood levels of TGF-ß1 on the day before embryo transfer
Time frame: 1 day
Blood levels of IFγ (Interferon gamma) on the day before embryo transfer
Blood levels of IFγ on the day before embryo transfer
Time frame: 1 day
Blood levels of PIBF (Progesterone induced blocking factor) on the day before embryo transfer
Blood levels of PIBF on the day before embryo transfer
Time frame: 1 day
Blood levels of IL-4 (Interleukin 4) on the day of embryo transfer
Blood levels of IL-4 on the day of embryo transfer
Time frame: 1 day
Blood levels of IL-10 (Interleukin 10) on the day of embryo transfer
Blood levels of IL-10 on the day of embryo transfer
Time frame: 1 day
Blood levels of IL-17 (Interleukin 17) on the day of embryo transfer
Blood levels of IL-17 on the day of embryo transfer
Time frame: 1 day
Blood levels of TGF-ß1 (Transforming Growth Factor beta1) on the day of embryo transfer
Blood levels of TGF-ß1 on the day of embryo transfer
Time frame: 1 day
Blood levels of IFγ (Interferon gamma) on the day of embryo transfer
Blood levels of IFγ on the day of embryo transfer
Time frame: 1 day
Blood levels of PIBF (Progesterone induced blocking factor) on the day of embryo transfer
Blood levels of PIBF on the day of embryo transfer
Time frame: 1 day
Blood levels of IL-4 (Interleukin 4) three days after embryo transfer
Blood levels of IL-4 three days after embryo transfer
Time frame: 3 days
Blood levels of IL-10 (Interleukin 10) three days after embryo transfer
Blood levels of IL-10 three days after embryo transfer
Time frame: 3 days
Blood levels of IL-17 (Interleukin 17) three days after embryo transfer
Blood levels of IL-17 three days after embryo transfer
Time frame: 3 days
Blood levels of TGF-ß1 (Transforming Growth Factor beta1) three days after embryo transfer
Blood levels of TGF-ß1 three days after embryo transfer
Time frame: 3 days
Blood levels of IFγ (Interferon gamma) three days after embryo transfer
Blood levels of IFγ three days after embryo transfer
Time frame: 3 days
Blood levels of PIBF (Progesterone induced blocking factor) three days after embryo transfer
Blood levels of PIBF three days after embryo transfer
Time frame: 3 days
Blood levels of IL-4 (Interleukin 4) ten days after embryo transfer
Blood levels of IL-4 ten days after embryo transfer
Time frame: 10 days
Blood levels of IL-10 (Interleukin 10) ten days after embryo transfer
Blood levels of IL-10 ten days after embryo transfer
Time frame: 10 days
Blood levels of IL-17 (Interleukin 17) ten days after embryo transfer
Blood levels of IL-17 ten days after embryo transfer
Time frame: 10 days
Blood levels of TGF-ß1 (Transforming Growth Factor beta1) ten days after embryo transfer
Blood levels of TGF-ß1 ten days after embryo transfer
Time frame: 10 days
Blood levels of IFγ (Interferon gamma) ten days after embryo transfer
Blood levels of IFγ ten days after embryo transfer
Time frame: 10 days
Blood levels of PIBF (Progesterone induced blocking factor) ten days after embryo transfer
Blood levels of PIBF ten days after embryo transfer
Time frame: 10 days
Blood levels of IL-4 (Interleukin 4) in case of pregnancy at 5 weeks +/- 3 days
Blood levels of IL-4 in case of pregnancy at 5 weeks +/- 3 days
Time frame: 5 weeks
Blood levels of IL-10 (Interleukin 10) in case of pregnancy at 5 weeks +/- 3 days
Blood levels of IL-10 in case of pregnancy at 5 weeks +/- 3 days
Time frame: 5 weeks
Blood levels of IL-17 (Interleukin 17) in case of pregnancy at 5 weeks +/- 3 days
Blood levels of IL-17 in case of pregnancy at 5 weeks +/- 3 days
Time frame: 5 weeks
Blood levels of TGF-ß1 (Transforming Growth Factor beta1) in case of pregnancy at 5 weeks +/- 3 days
Blood levels of TGF-ß1 in case of pregnancy at 5 weeks +/- 3 days
Time frame: 5 weeks
Blood levels of IFγ (Interferon gamma) in case of pregnancy at 5 weeks +/- 3 days
Blood levels of IFγ in case of pregnancy at 5 weeks +/- 3 days
Time frame: 5 weeks
Blood levels of PIBF (Progesterone induced blocking factor) in case of pregnancy at 5 weeks +/- 3 days
Blood levels of PIBF in case of pregnancy at 5 weeks +/- 3 days
Time frame: 5 weeks
Blood levels of estradiol on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
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 progesterone on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
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 estradiol on the day before embryo transfer
Blood levels of estradiol on the day before embryo transfer
Time frame: 1 day
Blood levels of progesterone on the day before embryo transfer
Blood levels of progesterone on the day before embryo transfer
Time frame: 1 day
Blood levels of estradiol on the day of embryo transfer
Blood levels of estradiol on the day of embryo transfer
Time frame: 1 day
Blood levels of progesterone on the day of embryo transfer
Blood levels of progesterone on the day of embryo transfer
Time frame: 1 day
Blood levels of estradiol three days after embryo transfer
Blood levels of estradiol three days after embryo transfer
Time frame: 3 days
Blood levels of progesterone three days after embryo transfer
Blood levels of progesterone three days after embryo transfer
Time frame: 3 days
Blood levels of estradiol ten days after embryo transfer
Blood levels of estradiol ten days after embryo transfer
Time frame: 10 days
Blood levels of progesterone ten days after embryo transfer
Blood levels of progesterone ten days after embryo transfer
Time frame: 10 days
Blood levels of estradiol in case of pregnancy at 5 weeks +/- 3 days
Blood levels of estradiol 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
Blood levels of progesterone in case of pregnancy at 5 weeks +/- 3 days
Time frame: 5 weeks
Blood levels of ß-hCG (Beta-Human Chorionic Gonadotropin) three days after embryo transfer
Blood levels of ß-hCG three days after embryo transfer
Time frame: 3 days
Blood levels of ß-hCG (Beta-Human Chorionic Gonadotropin) ten days after embryo transfer
Blood levels of ß-hCG ten days after embryo transfer
Time frame: 10 days
Blood levels of ß-hCG (Beta-Human Chorionic Gonadotropin) in case of pregnancy at 5 weeks +/- 3 days
Blood levels of ß-hCG in case of pregnancy at 5 weeks +/- 3 days
Time frame: 5 weeks

Secondary outcomes

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
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
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

Study locations

1 of 1 sites recruiting

ART Fertility Clinics LLC
Abu Dhabi, Abu Dhabi Emirate 60202, United Arab Emirates
17 other open studies at this site →
Recruiting
- Barbara Lawrenz, PhD · Contact · suzan.samir@artfertilityclinics.com · +97102 652 8000
- Laura Marqueta Marques · Principal investigator
Recruiting

References and documents

Publications

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Individual participant data

Plan to share: Undecided

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05473273
Lead sponsor: ART Fertility Clinics LLC
Responsible party: Laura Marqueta Marques (Principal Investigator, ART Fertility Clinics LLC) — Principal investigator
First posted: Jul 25, 2022
Start date: Apr 24, 2023
Primary completion: Dec 30, 2026 (estimated)
Completion: Dec 30, 2026 (estimated)
Last update: Jun 25, 2026

Study contacts

BARBARA LAWRENZ, PhD

Contact

barbara.lawrenz@artfertilityclinics.com

97126528000 ext. 1108

SUZAN SAMIR

Contact

suzan.samir@artfertilityclinics.com

97126528000

LAURA MARQUETA MARQUES, Consultant

principal investigator · ART Fertility Clinics LLC

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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Other studies from this sponsor

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