Progesterone Levels During Ovulation and Luteal Phase
1 other identifier
observational
6
1 country
1
Brief Summary
Natural cycles are evaluated during fertility treatments for different therapeutic options, like insemination (IUI), time intercourse (TI) or frozen-thawed embryo transfers (FET). Two possible protocols can be used for natural cycles, with or without hCG trigger. Usually, studies including natural cycles consider both options as equivalent, not considering the possible bias that the exogenous hCG (human chorionic gonadotrophin) might have. In this prospective study, Investigators aim to evaluate the differences in the hormonal profile during the ovulation when it occurs spontaneously vs triggered with a bolus of hCG.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2021
CompletedStudy Start
First participant enrolled
September 23, 2021
CompletedFirst Posted
Study publicly available on registry
October 13, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedMarch 14, 2023
March 1, 2023
3 months
September 20, 2021
March 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in hormone levels
Small sample data will be analyzed with the use of non-parametric test like Wilcoxon test to a paired a test of difference in hormones levels of the patients represented in both cycles (PNC and MNC) (dependent samples). This test will be preferred due to non-independent interval or ratio data in addition not to meet the normality or homogeneity of variances assumptions as paired t-test. Hormonal pattern over the days (measured for some days during cycle 1 and cycle 2) will be analyzed using trend analysis (line fit).
35 days
Secondary Outcomes (2)
Number of visits in luteal phase
17 days
Luteal phase length
17 days
Study Arms (2)
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.
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.
Interventions
once the dominant follicle reaches 17mm or above, a bolus of 6500 rhCG (Ovitrelle, Merck-Serono) will be administered subcutaneously
Eligibility Criteria
healthy women with spontaneous ovulation
You may qualify if:
- Healthy women below 40 years
- Regular and Ovulatory cycles
You may not qualify if:
- Previous adnexal surgery
- Endometriosis
- PCOs
- Using hormonal contraception during the previous 2 months: OCP, progesterone IUD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ART Fertility Clinics LLC
Abu Dhabi, 60202, United Arab Emirates
Related Publications (5)
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.
PMID: 17367920BACKGROUNDFatemi 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.
PMID: 20097333BACKGROUNDKyrou 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.
PMID: 22796236BACKGROUNDConnelly LM. Pilot studies. Medsurg Nurs. 2008 Dec;17(6):411-2. No abstract available.
PMID: 19248407BACKGROUNDHertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008 Apr;31(2):180-91. doi: 10.1002/nur.20247.
PMID: 18183564BACKGROUND
Related Links
Biospecimen
serum
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
LAURA MELADO, PhD
ART Fertility Clinics LLC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 20, 2021
First Posted
October 13, 2021
Study Start
September 23, 2021
Primary Completion
December 30, 2021
Study Completion
December 30, 2021
Last Updated
March 14, 2023
Record last verified: 2023-03