Clinical trial NCT03887728: Comparison of Blood Flow in the Arteriae Uterinae in Ovarian Stimulation Cycles
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrial Receptivity
Keywords: progesterone
endometrium
blood flow
estradiol
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
First posted: 2019-03-25
Enrollment: 124
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with primary / secondary infertility, who undergo an ovarian stimulation treatment for IVF/ICSI and subsequently are planned for FET with vitrified embryos, either as HRT-FET or as NC-FET

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

Eligibility criteria: 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

Primary outcomes:
measure: Difference in the blood flow, calculated as Pulsatility Index (PI) and Resistance Index (RI), between the HRT- and the NC-FET cycles
timeFrame: 1 day
Secondary outcomes:
measure: Continuous quantitative variable measured as the differences between average PI value
timeFrame: 1 day
measure: Continuous quantitative variable measured as the differences between average RI value
timeFrame: 2 days
measure: Thickness of the lining
timeFrame: 1 day
measure: Number of days of estradiol exposure
timeFrame: 1 day
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: IVI Middle East Fertility Clinic
Study officials:
affiliation: IVI RMA Abu Dhabi
name: Barbara Lawrenz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdalla HI, Brooks AA, Johnson MR, Kirkland A, Thomas A, Studd JW. Endometrial thickness: a predictor of implantation in ovum recipients? Hum Reprod. 1994 Feb;9(2):363-5. doi: 10.1093/oxfordjournals.humrep.a138509.
citation: Noyes N, Liu HC, Sultan K, Schattman G, Rosenwaks Z. Endometrial thickness appears to be a significant factor in embryo implantation in in-vitro fertilization. Hum Reprod. 1995 Apr;10(4):919-22. doi: 10.1093/oxfordjournals.humrep.a136061.
citation: Bakos O, Lundkvist O, Bergh T. Transvaginal sonographic evaluation of endometrial growth and texture in spontaneous ovulatory cycles--a descriptive study. Hum Reprod. 1993 Jun;8(6):799-806. doi: 10.1093/oxfordjournals.humrep.a138145.
citation: Tekay A, Martikainen H, Jouppila P. Comparison of uterine blood flow characteristics between spontaneous and stimulated cycles before embryo transfer. Hum Reprod. 1996 Feb;11(2):364-8. doi: 10.1093/humrep/11.2.364.
citation: Romero R. Giants in Obstetrics and Gynecology Series: A profile of Leon Speroff, MD. Am J Obstet Gynecol. 2017 Sep;217(3):263.e1-263.e8. doi: 10.1016/j.ajog.2017.05.056. Epub 2017 Jul 12. No abstract available.
citation: Ferraretti AP, La Marca A, Fauser BC, Tarlatzis B, Nargund G, Gianaroli L; ESHRE working group on Poor Ovarian Response Definition. ESHRE consensus on the definition of 'poor response' to ovarian stimulation for in vitro fertilization: the Bologna criteria. Hum Reprod. 2011 Jul;26(7):1616-24. doi: 10.1093/humrep/der092. Epub 2011 Apr 19.
citation: Irani M, Robles A, Gunnala V, Reichman D, Rosenwaks Z. Optimal parameters for determining the LH surge in natural cycle frozen-thawed embryo transfers. J Ovarian Res. 2017 Oct 16;10(1):70. doi: 10.1186/s13048-017-0367-7.
citation: Fatemi HM, Kyrou D, Bourgain C, Van den Abbeel E, Griesinger G, Devroey P. Cryopreserved-thawed human embryo transfer: spontaneous natural cycle is superior to human chorionic gonadotropin-induced natural cycle. Fertil Steril. 2010 Nov;94(6):2054-8. doi: 10.1016/j.fertnstert.2009.11.036. Epub 2010 Jan 25.