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

Endometrial Receptivity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03887728
• Other study ID #: 1901-ABU-002-BL
• Status: Completed
• Start date: April 23, 2019
• Est. completion date: December 14, 2020

Study information

• Verified date: January 2021
• Source: ART Fertility Clinics LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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 information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: December 14, 2020
• Est. primary completion date: September 26, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Receptivity

Locations

Country	Name	City	State
United Arab Emirates	IVI Middle East Fertility Clinic	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
ART Fertility Clinics LLC

Country where clinical trial is conducted

United Arab Emirates, 

References & Publications (8)

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. — View 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. — View 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: — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the blood flow, calculated as Pulsatility Index (PI) and Resistance Index (RI), between the HRT- and the NC-FET cycles	On the day of progesterone administration / progesterone rise. Quantitative continuous variable	1 day
Secondary	Continuous quantitative variable measured as the differences between average PI value	On the day of cycle start and the day of ovulation induction. Continuous quantitative variable measured in millimeters (mm)	1 day
Secondary	Continuous quantitative variable measured as the differences between average RI value	On the day of cycle start and the day of ovulation induction	2 days
Secondary	Thickness of the lining	Continuous quantitative variable measured in millimeters (mm)	1 day
Secondary	Number of days of estradiol exposure	Before the embryo transfer	1 day

External Links

•   Clinical Gynecologic Endocrinology and Infertility Part 1. Reproductive Physiology. Chapter 6: Regulation of the Menstrual Cycle. Ovulation : 212-216p.