Actively Recruiting

Age: 18Years - 40Years
FEMALE
Healthy Volunteers
ID05473273

Descriptive Analysis of Serum Immunological Markers During an Euploid Frozen Embryo Transfer in a Natural Cycle or Hormone Replacement Therapy Protocol

Led by ART Fertility Clinics LLC · Updated on 2025-02-21

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the levels of specific immune system proteins in the blood during a frozen embryo transfer process in women undergoing fertility treatment. This observational study focuses on measuring both anti-inflammatory and pro-inflammatory markers, as well as an immune mediator called Progesterone-Induced Blocking Factor (PIBF), during a single euploid blastocyst transfer in either a natural cycle or hormone replacement therapy cycle. The goal is to better understand how these markers change at key stages of embryo implantation. The study includes two protocols: a natural cycle where ovulation is tracked by ultrasound and hormone levels, with embryo transfer scheduled five days after ovulation; and a hormone replacement therapy cycle where estrogen and progesterone medications are given to prepare the uterus before embryo transfer. Blood samples are taken multiple times around the embryo transfer day and following days to measure immune markers and pregnancy hormone levels. If pregnancy occurs, an additional blood test is done at about five weeks. Participants will undergo ultrasound monitoring and blood tests at several points, including the day of ovulation or first progesterone dose, the day before embryo transfer, the day of transfer, and three and ten days afterward. Pregnancy is confirmed with hormone tests, and immune marker levels are reassessed in early pregnancy. The study aims to collect these detailed measurements over approximately one year to observe immune changes related to embryo implantation and pregnancy outcomes.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 40Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 years to 40 years
  • Having at least one good quality (grade A or B) day 5 or 6 chromosomally normal cryopreserved blastocyst available for transfer
  • Single embryo transfer in a natural cycle (NC) or a Hormone Replacement Therapy (HRT) protocol
  • Fresh ejaculate used for fertilization
Not Eligible

You will not qualify if you...

  • Body mass index lower than 18.5 or equal or higher than 29 kg/m2
  • Endometriosis or adenomyosis suspected by medical history or diagnosed by imaging
  • Uterine abnormalities
  • Hydrosalpinx
  • Insulin resistance or diabetes mellitus diagnosed by HbA1c 5.7 % or higher
  • Antiphospholipid syndrome
  • Polycystic ovarian syndrome according to Rotterdam criteria
  • History of recurrent miscarriage (2 or more pregnancy losses)
  • History of implantation failure after transfer of 2 good-quality euploid embryos
  • History or suspicion of Asherman syndrome
  • Autoimmune disease
  • Couple first degree consanguineous

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Ultrasound and blood tests to assess eligibility

Monitoring

Duration - Up to 4 weeks

Participants undergo ultrasound monitoring and serial blood tests to track hormonal levels and immune markers during either a natural cycle or hormone replacement therapy protocol leading up to embryo transfer.

Multiple visits for ultrasound and blood sampling according to cycle phase

Treatment

Duration - Approximately 2 weeks including embryo transfer and follow-up blood tests

Participants receive a single embryo transfer and hormone supplementation as needed, with blood samples collected at specific time points to measure immunological markers and hormone levels.

Blood tests on the day before embryo transfer, day of transfer, and 3 and 10 days after embryo transfer

Long-term Monitoring

Duration - 5 weeks +/- 3 days after embryo transfer

In case of pregnancy, participants have an additional blood test about 5 weeks after embryo transfer to measure immunological and pregnancy hormone markers.

1 visit for blood sampling

Trial Site Locations

Total: 1 location

1

ART Fertility Clinics LLC

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

Actively Recruiting

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Research Team

B

BARBARA LAWRENZ, PhD

S

SUZAN SAMIR

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Effects of Progesterone, Dydrogesterone and Estrogen on the Production of Th1/Th2/Th17 Cytokines by Lymphocytes from Women with Recurrent Spontaneous Miscarriage.

Ghadeer AbdulHussain, Fawaz Azizieh, Ma'asoumah Makhseed...

https://pubmed.ncbi.nlm.nih.gov/32380371