Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
6 participants
OBSERVATIONAL
2021-09-23
2021-12-30
Brief Summary
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Detailed Description
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For the modified natural cycle (MNC), a bolus of rhCG 6500 IU subcutaneous (sc) will be administered when 1 dominant follicle reaches 17mm or above, after excluding previous LH surge. This is the first prospective study where the differences on the hormonal profile for ovulation will be studied.
HYPOTHESIS:
H0: The hormonal profile is not different between the PNC and the MNC H1: The hormonal profile is different between the PNC and MNC
Administration of hCG is a popular method for triggering ovulation since it may avoid the need to perform IUI or FET at weekends. However, it is an intervention compared with the detection of the spontaneous LH rise. Moreover, due to the presence of hCG receptors in the human endometrium, administration of hCG might interfere with endometrial receptivity. Previous publications evaluating pregnancy rates demonstrated that the use of hCG injection during the natural cycle reduces the pregnancy rates, in FET and IUI. It remains unclear what might be the mechanism to explain the lower pregnancy rates: a possible direct effect of hCG on the hCG receptors of the endometrium or a modification of the hormonal profile after the administration of the hCG, affecting the window of implantation (WOI).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Pure Natural Cycle
* Transvaginal ultrasound (TVUS) on day 2/3 of cycle + hormones FSH, LH, E2, P4 (IVF1)
* TVUS day 9-10 of cycle to identify dominant follicle.
* Blood test for IVF1 every 24h until identification of the LH surge.
* The LH surge will be diagnosed when the concentration rises by 180% above the latest serum value available in that patient and continued to rise thereafter (Fatemi et al, 2010).
* Once the LH rise is detected, blood test for IVF1 to be performed after 2h, and then every 12h after LH rise for 2 days.
* During luteal phase, IVF1 day 7 after LH rise and day 14 after LH rise.
No interventions assigned to this group
Modified Natural Cycle
* Transvaginal ultrasound (TVUS) on day 2/3 of cycle + hormones FSH, LH, E2, P4 (IVF1)
* TVUS day 9-10 of cycle to identify dominant follicle.
* Once the dominant follicle reaches 17mm or above, a bolus of 6500 rhCG (Ovitrelle, Merck-Serono) will be administered subcutaneously. IVF1 to be performed just before the rhCG-administration.
* IVF1 2h after rhCG.
* IVF1 every 12h for 2 days after rhCG.
* During luteal phase, IVF1 day 7 after rhCG and day 14 after rhCG.
human chorionic gonadotropin
once the dominant follicle reaches 17mm or above, a bolus of 6500 rhCG (Ovitrelle, Merck-Serono) will be administered subcutaneously
Interventions
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human chorionic gonadotropin
once the dominant follicle reaches 17mm or above, a bolus of 6500 rhCG (Ovitrelle, Merck-Serono) will be administered subcutaneously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Regular and Ovulatory cycles
Exclusion Criteria
* Endometriosis
* PCOs
* Using hormonal contraception during the previous 2 months: OCP, progesterone IUD
18 Years
39 Years
FEMALE
Yes
Sponsors
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ART Fertility Clinics LLC
OTHER
Responsible Party
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Laura Melado
Principal Investigator
Principal Investigators
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LAURA MELADO, PhD
Role: PRINCIPAL_INVESTIGATOR
ART Fertility Clinics LLC
Locations
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ART Fertility Clinics LLC
Abu Dhabi, , United Arab Emirates
Countries
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References
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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.
Kyrou D, Kolibianakis EM, Fatemi HM, Grimbizis GF, Theodoridis TD, Camus M, Tournaye H, Tarlatzis BC, Devroey P. Spontaneous triggering of ovulation versus HCG administration in patients undergoing IUI: a prospective randomized study. Reprod Biomed Online. 2012 Sep;25(3):278-83. doi: 10.1016/j.rbmo.2012.05.005. Epub 2012 May 23.
Connelly LM. Pilot studies. Medsurg Nurs. 2008 Dec;17(6):411-2. No abstract available.
Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.
Licht P, Fluhr H, Neuwinger J, Wallwiener D, Wildt L. Is human chorionic gonadotropin directly involved in the regulation of human implantation? Mol Cell Endocrinol. 2007 Apr 15;269(1-2):85-92. doi: 10.1016/j.mce.2006.09.016. Epub 2007 Feb 14.
Related Links
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van Belle, G. (2002). Statistical rules of thumb. New York: John Wiley
Other Identifiers
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2107-ABU-009-LM
Identifier Type: -
Identifier Source: org_study_id
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