Comparison of Blood Flow in the Arteriae Uterinae in Ovarian Stimulation Cycles
NCT ID: NCT03887728
Last Updated: 2021-01-08
Study Results
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Basic Information
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COMPLETED
124 participants
OBSERVATIONAL
2019-04-23
2020-12-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Artificial (HRT) Cycles
1. Commence estradiol tablets (E2) 4mg from day 2 or 3 of period for 3 days
2. Increase E2 to 6mg on day 4 of E2 treatment, according to clinician discretion based on endometrial thickness.
3. Transvaginal scan throughout the HRT cycle to not only monitor endometrial development but to also exclude the presence of a dominant follicle on the ovaries.
4. Serial measurements of serum LH (luteinizing hormone), estradiol and progesterone levels.
5. Initial progesterone dose of 100mg at 22hrs (vaginal suppository) after ≥ 10 days and ≤ 16 days of estradiol administration when the minimal endometrial thickness achieved is 6mm with a trilaminar appearance.
6. Subsequently increase progesterone administration to 100mg vaginally three times daily. Continue E2 administration 6mg (3 tablets daily). Embryo transfer is scheduled 5 days following the initial initiation of progesterone
No interventions assigned to this group
Spontaneous natural cycles
1. Day 2 of menses and throughout patients' natural cycle scans to monitor follicular growth.
2. Measurements of serum LH, estradiol and progesterone levels to determine ovulation.
3. The LH surge will be considered to have begun when the concentration rises by 180% above the most recent serum value and continues to rise thereafter (Irani et al. 2017, Fatemi et al., 2010).
4. Day 1 after the LH rise, a decrease in estradiol concentration is identified. Twenty four hours later progesterone concentrations rise with a level of greater than or equal to 1.5nmol /L confirming ovulation (day 0) (Irani et al., 2017; Speroff et al.). This is considered as day 0 with initiation of vaginal progesterone 100mg at 22hrs that night. The following day (day 1) the patient increases progesterone administration to 100mg vaginally 8 hourly and continues until 7 weeks gestation as per clinic protocol. Embryo transfer is scheduled 5 days (day 5) following confirmation of ovulation (day 0).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Patients who have vitrified embryo(s)
* Preparation for FET either in HRT or NC cycle
Exclusion Criteria
* 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
FEMALE
Yes
Sponsors
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ART Fertility Clinics LLC
OTHER
Responsible Party
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Barbara Lawrenz
Scientific Director
Principal Investigators
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Barbara Lawrenz, PhD
Role: PRINCIPAL_INVESTIGATOR
IVI RMA Abu Dhabi
Locations
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IVI Middle East Fertility Clinic
Abu Dhabi, , United Arab Emirates
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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1901-ABU-002-BL
Identifier Type: -
Identifier Source: org_study_id
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