Progesterone Diurnal Rhythm During Ovarian Stimulation for IVF
Study Details
Study Description
Brief Summary
To evaluate the influence of circadian rhythm on progesterone levels during follicular phase of natural cycle and during follicular phase of controlled ovarian stimulation during IVF.
Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
The primary aim of this study is to determine the circadian rhythm of progesterone in a stimulated cycle. Sample size calculations show that the study needs to recruit 10 women to show any significant differences in progesterone secreted in the morning at 8 am compared to that secreted in the evening at 8 pm. We have increased the number of participants to 12 in order to compensate for any possible drop outs. The hormones FSH, LH, Progesterone and Estradiol will be measured at days 2/3, 8, 10 and 12 of a normal and stimulated cycle so that each patient serves as her own control.
This study will provide the basis to establish the optimal blood sampling time for progesterone measurement and to more accurately determine the cut-off level for progesterone for favourable pregnancy outcomes in ART.
Study Design
Outcome Measures
Primary Outcome Measures
- Progesterone levels during follicular phase [2-4 months]
The primary aim of this study is to determine the circadian rhythm of progesterone in a stimulated cycle.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Indication for IVF / ICSI - treatment
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Age ≥ 18 years and ≤ 35 years
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Ovarian reserve parameters in the adequate age - range, determined by Anti-Mullerian-Hormone (AMH) and Antral Follicle Count (AFC)(16)
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Able to understand the aim of the study and to provide consent
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Regular cycle (25-35 days)
Exclusion Criteria:
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Diagnosis of polycystic ovarian syndrome (PCOS) Rotterdam criteria
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Endometriosis stage 3 or 4 AFS
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Treatment with GnRH-analogues during the previous 6 months
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Intake of oral contraceptive pill (OCP) or any hormonal treatment during the last 3 months
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | IVI Middle East Fertilty Clinic | Abu Dhabi | United Arab Emirates |
Sponsors and Collaborators
- ART Fertility Clinics LLC
Investigators
- Principal Investigator: Human Mo Fatemi, Medical Director, IVI Middle East Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Fatemi HM, Van Vaerenbergh I. Significance of premature progesterone rise in IVF. Curr Opin Obstet Gynecol. 2015 Jun;27(3):242-8. doi: 10.1097/GCO.0000000000000172. Review.
- Patton PE, Lim JY, Hickok LR, Kettel LM, Larson JM, Pau KY. Precision of progesterone measurements with the use of automated immunoassay analyzers and the impact on clinical decisions for in vitro fertilization. Fertil Steril. 2014 Jun;101(6):1629-36. doi: 10.1016/j.fertnstert.2014.02.037. Epub 2014 Mar 21.
- 1609-ABU-070-HF