Comparison of Blood Flow in the Arteriae Uterinae in Ovarian Stimulation Cycles
- Conditions
- Endometrial Receptivity
- Registration Number
- NCT03887728
- Lead Sponsor
- ART Fertility Clinics LLC
- Brief Summary
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)
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 124
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Difference in the blood flow, calculated as Pulsatility Index (PI) and Resistance Index (RI), between the HRT- and the NC-FET cycles 1 day On the day of progesterone administration / progesterone rise. Quantitative continuous variable
- Secondary Outcome Measures
Name Time Method Number of days of estradiol exposure 1 day Before the embryo transfer
Continuous quantitative variable measured as the differences between average RI value 2 days On the day of cycle start and the day of ovulation induction
Thickness of the lining 1 day Continuous quantitative variable measured in millimeters (mm)
Continuous quantitative variable measured as the differences between average PI value 1 day On the day of cycle start and the day of ovulation induction. Continuous quantitative variable measured in millimeters (mm)
Trial Locations
- Locations (1)
IVI Middle East Fertility Clinic
🇦🇪Abu Dhabi, United Arab Emirates