Analysis of immune markers during frozen embryo transfer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: barbara.lawrenz@artfertilityclinics.com
• Phone: 97126528000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.