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Variation of Progesterone in IVF Cycles

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ClinicalTrials.gov Identifier: NCT03519776
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
IVI Middle East Fertility Clinic

Brief Summary:
to examine if a natural daytime variation in progesterone levels may explain parts of the inconsistent findings from studies reporting divergent results concerning this matter and will be carried out by several blood samples from the same patient during the day of ovulation triggering.

Condition or disease Intervention/treatment
Progesterone Resistance Diagnostic Test: Progesterone variation

Detailed Description:
The impact of the progesterone level at the end of the follicular phase in stimulated IVF/ICSI cycles and its effect on the pregnancy rate and oocyte quality is controversial, which arises from conflicting results in retrospective studies and meta-analyses. This study is assumed to examine if a natural daytime variation in progesterone levels may explain parts of the inconsistent findings from studies reporting divergent results concerning this matter and will be carried out by several blood samples from the same patient during the day of ovulation triggering. If variation is present, the impact of variation on the developing oocyte and embryo quality will be estimated by embryo quality indicators.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Variation of Progesterone in IVF Cycles
Actual Study Start Date : May 10, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: Progesterone variation
    The potential gain for medical caretakers and patients would be a certainty if the progesterone level is affected by variations during daytime


Primary Outcome Measures :
  1. The variation of serum progesterone around the ovulation triggering in IVF-cycles [ Time Frame: 6-8 months ]
    the circadian secretion-pattern of progesterone during early follicular phase of normal cycling females


Biospecimen Retention:   Samples With DNA
Blood will be drawn. Each blood sample will consist of 10 cc of blood, to be centrifuged and the serum shared into 3 vials before freezing at minus 20 degrees.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patient who will undergo IVF treatment
Criteria

Inclusion Criteria:

  • patients 18-45 years
  • BMI 18-35 kg/m2
  • Menstrual cycle length 24-35 days
  • Stimulation with rFSH or hMG

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519776


Contacts
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Contact: Upma Shanker 0096895265200 Upma.shanker@ivirma.com

Locations
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United Arab Emirates
IVI Middle East Fertilty Clinic Recruiting
Abu Dhabi, United Arab Emirates
Contact: IVI Middle East Fertility clinic    +97126528000    info@ivirma.com   
Principal Investigator: Human Fatemi         
Sponsors and Collaborators
IVI Middle East Fertility Clinic
Investigators
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Principal Investigator: Upma Shanker IVI Middle East Fertility Clinic

Publications:

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Responsible Party: IVI Middle East Fertility Clinic
ClinicalTrials.gov Identifier: NCT03519776     History of Changes
Other Study ID Numbers: 1710-MUS-106-LB
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: November 9, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs