Skip to main content
OpenTrials
Completed

NCT Number: NCT03887728

Comparison of Blood Flow in the Arteriae Uterinae in Ovarian Stimulation Cycles

This study will measure the blood flow in the aa. uterinae in women, undergoing firstly ovarian stimulation for In-Vitro Fertilization (IVF) / Intracytoplasmic sperm injection (ICSI), in Hormonal Replacement cycles (HRT) and Natural cycles (NC) for Frozen Embryo Transfer (FET)

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

Female

Study type

Observational

Primary location

IVI Middle East Fertility Clinic

Abu Dhabi, 60202, United Arab Emirates

About this study

To evaluate the influence of ovarian stimulation on the blood flow in the arteriae uterinae as well as whether there is an influence of the type of endometrial preparation for FET with either hormonal replacement therapy or natural cycle on the blood flow of the arteria uterina left / right

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients who undergo ovarian stimulation in a Gonadotropin-Releasing-Hormone (GnRH)-antagonist protocol for IVF / ICSI
  • Patients who have vitrified embryo(s)
  • Preparation for FET either in HRT or NC cycle

Exclusion criteria

  • Poor responder according to Bologna criteria (Ferraretti et al.) as follows:
  • At least two of the following three features must be present:
  • (i) Advanced maternal age (≥40 years) or any other risk factor for poor ovarian reserve (POR);
  • (ii) A previous POR (≤3 oocytes with a conventional stimulation protocol);
  • (iii) An abnormal ovarian reserve test (i.e. antral follicle count (AFC) 5-7 follicles or anti-mullerian hormone (AMH) 0.5 -1.1 ng/ml).
  • Uterine surgery for removal of fibroids (hysteroscopic, laparoscopic) or removal of uterine septum
  • Endometriosis
  • Asherman-Syndrome
  • Previous cytotoxic treatment
  • Previous radiation of the uterus / adnexal region
  • Known hypertension
  • Intake of Aspirin or similar medication which might influence the blood flow
  • Status after tubal ligation
  • Status after surgery in the adnexal region on 1 side

Treatment and study plan

Primary outcomes

  1. Difference in the blood flow, calculated as Pulsatility Index (PI) and Resistance Index (RI), between the HRT- and the NC-FET cycles

    Time frame: 1 day

    On the day of progesterone administration / progesterone rise. Quantitative continuous variable

Secondary outcomes

  1. Continuous quantitative variable measured as the differences between average PI value

    Time frame: 1 day

    On the day of cycle start and the day of ovulation induction. Continuous quantitative variable measured in millimeters (mm)

  2. Continuous quantitative variable measured as the differences between average RI value

    Time frame: 2 days

    On the day of cycle start and the day of ovulation induction

  3. Thickness of the lining

    Time frame: 1 day

    Continuous quantitative variable measured in millimeters (mm)

  4. Number of days of estradiol exposure

    Time frame: 1 day

    Before the embryo transfer

Sponsors and collaborators

Lead sponsor

ART Fertility Clinics LLC

Other

Registry information

Official study title

Comparison of Blood Flow in the Arteriae Uterinae in Ovarian Stimulation Cycles for IVF/ICSI, in Hormonal Replacement Cycles and Natural Cycles for Frozen Embryo Transfer

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 25, 2019
Registry last updated
Jan 8, 2021

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.

Published trials that share one or more normalized conditions with this study.