Analysis of immune markers during frozen embryo transfer

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

This study looks at changes in immune markers in women aged 18 to 40 who are having a frozen embryo transfer to see how these markers might affect their chances of pregnancy.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: ART Fertility Clinics LLC (other)
• Locations: 1 site (Abu Dhabi, Abu Dhabi Emirate)
• Trial ID: NCT05473273 on ClinicalTrials.gov

What this trial studies

This observational study aims to analyze the levels of specific serum immunological markers in women undergoing a single frozen euploid blastocyst transfer. It will measure both anti-inflammatory and pro-inflammatory cytokines, as well as immune mediators, at various stages of the embryo transfer process. Blood samples will be collected on the day of ovulation or the first day of progesterone, on the day of embryo transfer, and at subsequent intervals to assess changes in these markers. The study will include 40 infertile women aged 18 to 40 and is expected to be completed within 12 months.

Who should consider this trial

Good fit: Ideal candidates are women aged 18 to 40 with at least one good quality chromosomally normal cryopreserved blastocyst available for transfer.

Not a fit: Patients with conditions such as endometriosis, uterine abnormalities, or those with a BMI outside the specified range may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of immune responses during embryo transfer, potentially improving outcomes for women undergoing fertility treatments.

How similar studies have performed: While similar studies have explored cytokine levels in fertility treatments, this specific analysis of immune markers during frozen embryo transfer is relatively novel.

Eligibility criteria

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

Where this trial is running

Abu Dhabi, Abu Dhabi Emirate

• ART Fertility Clinics LLC — Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates (RECRUITING)

Study contacts

• Principal investigator: LAURA MARQUETA MARQUES, Consultant — ART Fertility Clinics LLC
• Study coordinator: BARBARA LAWRENZ, PhD

Conditions: Infertility, Female, infertilty, ivf, progesterone, estradiol, cytokines, immunology, Pharmacological effect of drugs