Corpus Luteum Function and Cardiovascular Adaptation in a Natural MOCK Cycle. (CLEAR)
Studieoversigt
Status
Status
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Tilmelding (Anslået)
Tilmelding
Kontakter og lokationer
Studiekontakt
Studiekontakt
- Navn: Caroline Roelens
- Telefonnummer: 0032 2 477 9887
- E-mail: caroline.roelens@uzbrussel.be
Studiesteder
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Jette, Belgien, 1090
- UZ Brussel
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Kontakt:
- Caroline Roelens
- Telefonnummer: 0032 2 477 9887
- E-mail: caroline.roelens@uzbrussel.be
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-
Deltagelseskriterier
Berettigelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Age below 40 years
- Regular menstrual cycles (between 25-35 days)
- Normal BMI between 18.5 and 35
Exclusion Criteria:
- Underlying renal or cardiac disease
- Hypertension
- Diabetes mellitus
- Contraceptive use less than 3 months before MOCK cycle, including: IUD (hormonal and copper), hormonal patch, contraceptive pill (combination and mini), hormonal intravaginal ring, contraceptive implant, contraceptive injection.
- Ovarian stimulation during the previous three months
- History of recurrent pregnancy loss (defined as 2 or more previous pregnancy losses before 24 weeks gestation).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Antal grupper/kohorter
Kohorter og interventioner
Gruppe / kohorteGruppe / kohorte |
Intervention / BehandlingIntervention / Behandling |
|---|---|
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Follicle size 11mm
Patients with a follicle of 11mm when measured through transvaginal ultrasound in 2D, at time of ovulation induction.
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We will collect several blood samples:
A transvaginal ultrasound will be performed after day 8 of the cycle to evaluate a 2D measurement of the growing follicle, as well as a measurement of the endometrial thickness to evaluate readiness for ovulation induction.
The MAP will be measured at cycle day 7 and 7 days post-ovulation induction to follow cardiovascular adaptations.
When patient is deemed ready for ovulation based on follicle size, blood results and endometrium, she will be asked to inject Ovitrelle 250 micrograms to induce ovulation in a controlled and timed manner.
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Follicle size 12 mm
Patients with a follicle of 12mm when measured through transvaginal ultrasound in 2D, at time of ovulation induction.
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We will collect several blood samples:
A transvaginal ultrasound will be performed after day 8 of the cycle to evaluate a 2D measurement of the growing follicle, as well as a measurement of the endometrial thickness to evaluate readiness for ovulation induction.
The MAP will be measured at cycle day 7 and 7 days post-ovulation induction to follow cardiovascular adaptations.
When patient is deemed ready for ovulation based on follicle size, blood results and endometrium, she will be asked to inject Ovitrelle 250 micrograms to induce ovulation in a controlled and timed manner.
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Follicle size 13 mm
Patients with a follicle of 13mm when measured through transvaginal ultrasound in 2D, at time of ovulation induction.
|
We will collect several blood samples:
A transvaginal ultrasound will be performed after day 8 of the cycle to evaluate a 2D measurement of the growing follicle, as well as a measurement of the endometrial thickness to evaluate readiness for ovulation induction.
The MAP will be measured at cycle day 7 and 7 days post-ovulation induction to follow cardiovascular adaptations.
When patient is deemed ready for ovulation based on follicle size, blood results and endometrium, she will be asked to inject Ovitrelle 250 micrograms to induce ovulation in a controlled and timed manner.
|
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Follicle size 14 mm
Patients with a follicle of 14mm when measured through transvaginal ultrasound in 2D, at time of ovulation induction.
|
We will collect several blood samples:
A transvaginal ultrasound will be performed after day 8 of the cycle to evaluate a 2D measurement of the growing follicle, as well as a measurement of the endometrial thickness to evaluate readiness for ovulation induction.
The MAP will be measured at cycle day 7 and 7 days post-ovulation induction to follow cardiovascular adaptations.
When patient is deemed ready for ovulation based on follicle size, blood results and endometrium, she will be asked to inject Ovitrelle 250 micrograms to induce ovulation in a controlled and timed manner.
|
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Follicle size 15 mm
Patients with a follicle of 15mm when measured through transvaginal ultrasound in 2D, at time of ovulation induction.
|
We will collect several blood samples:
A transvaginal ultrasound will be performed after day 8 of the cycle to evaluate a 2D measurement of the growing follicle, as well as a measurement of the endometrial thickness to evaluate readiness for ovulation induction.
The MAP will be measured at cycle day 7 and 7 days post-ovulation induction to follow cardiovascular adaptations.
When patient is deemed ready for ovulation based on follicle size, blood results and endometrium, she will be asked to inject Ovitrelle 250 micrograms to induce ovulation in a controlled and timed manner.
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Follicle size 16 mm
Patients with a follicle of 16mm when measured through transvaginal ultrasound in 2D, at time of ovulation induction.
|
We will collect several blood samples:
A transvaginal ultrasound will be performed after day 8 of the cycle to evaluate a 2D measurement of the growing follicle, as well as a measurement of the endometrial thickness to evaluate readiness for ovulation induction.
The MAP will be measured at cycle day 7 and 7 days post-ovulation induction to follow cardiovascular adaptations.
When patient is deemed ready for ovulation based on follicle size, blood results and endometrium, she will be asked to inject Ovitrelle 250 micrograms to induce ovulation in a controlled and timed manner.
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Follicle size 17 mm
Patients with a follicle of 17mm when measured through transvaginal ultrasound in 2D, at time of ovulation induction.
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We will collect several blood samples:
A transvaginal ultrasound will be performed after day 8 of the cycle to evaluate a 2D measurement of the growing follicle, as well as a measurement of the endometrial thickness to evaluate readiness for ovulation induction.
The MAP will be measured at cycle day 7 and 7 days post-ovulation induction to follow cardiovascular adaptations.
When patient is deemed ready for ovulation based on follicle size, blood results and endometrium, she will be asked to inject Ovitrelle 250 micrograms to induce ovulation in a controlled and timed manner.
|
|
Follicle size 18 mm
Patients with a follicle of 18mm when measured through transvaginal ultrasound in 2D, at time of ovulation induction.
|
We will collect several blood samples:
A transvaginal ultrasound will be performed after day 8 of the cycle to evaluate a 2D measurement of the growing follicle, as well as a measurement of the endometrial thickness to evaluate readiness for ovulation induction.
The MAP will be measured at cycle day 7 and 7 days post-ovulation induction to follow cardiovascular adaptations.
When patient is deemed ready for ovulation based on follicle size, blood results and endometrium, she will be asked to inject Ovitrelle 250 micrograms to induce ovulation in a controlled and timed manner.
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Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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The relationship between progesterone levels and different follicular sizes on day 7 post ovulation induction.
Tidsramme: From the start of the menstrual cycle until 7 days after ovulation induction.
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Progesterone levels will be measured 7 days after ovulation induction to relate them to different follicular sizes.
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From the start of the menstrual cycle until 7 days after ovulation induction.
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Estradiol evolution throughout the cycle and its relation to luteal progesterone levels.
Tidsramme: From the start of a menstrual cycle until 7 days post-ovulation induction.
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We will measure the estradiol on different moments throught the menstural cycle, and see how these levels correspond to later (luteal) progesterone levels.
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From the start of a menstrual cycle until 7 days post-ovulation induction.
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Indirect factors reflecting cardiovascular and renal adaptation in the luteal phase
Tidsramme: From the start of the menstrual cycle until 7 days after ovulation induction.
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We will measure these factors (MAP, progesterone, estradiol, serum sodium, chloride, carbon dioxide and osmolality, prolactin, direct renin, plasma aldosterone, NT-proBNP, relaxin-2 and VEGF) at day 8 of the cycle, as well as 7 days after ovulation-induction.
All these factors form a reflection of the body's cardiovascular and renal adaptation, and will be studied to estimate these adaptation at different follicular sizes.
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From the start of the menstrual cycle until 7 days after ovulation induction.
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Samarbejdspartnere og efterforskere
Sponsor
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Studiestart
Primær færdiggørelse (Anslået)
Primær færdiggørelse
Studieafslutning (Anslået)
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Først opslået
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Hormoner
- Hormoner, hormonsubstitutter og hormonantagonister
- Peptidhormoner
- Peptider
- Aminosyrer, peptider og proteiner
- Proteiner
- Undersøgelsesteknikker
- Terapeutik
- Håndtering af eksemplar
- Kliniske laboratorieteknikker
- Diagnostiske teknikker og procedurer
- Diagnose
- Punkteringer
- Kirurgiske procedurer, operative
- Reproduktionsteknikker, assisteret
- Reproduktionsteknikker
- Gonadotropiner
- Placentale hormoner
- Graviditetsproteiner
- Choriongonadotropin
- Blodprøveopsamling
- Ægløsningsinduktion
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- EC-2025-445
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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