Health TrialsbyHealthPanel

Corpus Luteum Function and Cardiovascular Adaptation in a Natural MOCK Cycle.

ConditionsMenstrual CycleLuteal Phase Progesterone LevelsLuteal Phase AdaptationMOCK Cycle
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-40
SponsorUniversitair Ziekenhuis Brussel

About this trial

In infertility treatment, embryos are created in vitro after eggs have been fertilised by sperm using in vitro fertilisation or intracytoplasmic sperm injection techniques. These embryos, resulting from hormonal ovarian stimulation, can be transferred shortly after egg retrieval (fresh transfer) or frozen for later use. Both natural menstrual cycles and artificial cycles (using hormones to mimic a normal cycle) can prepare the uterus for embryo transfer. Patients with regular menstrual cycles often prefer the non-medicated approach. However, these cycles offer less flexibility in timing because they rely on ovulation. As the number of FET cycles increases worldwide, scientists are exploring the possibility of inducing ovulation in smaller follicles to increase the flexibility of natural cycles. However, the safety for future pregnancies is unknown. This study aims to better understand the function of the corpus luteum, the follicle remnant in the ovary after ovulation, by measuring several factors that change throughout the cycle due to substances produced by the corpus luteum. The results of the study will have a direct impact on clinical practice by increasing the flexibility of frozen transfer cycles.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age below 40 years

Regular menstrual cycles (between 25-35 days)

Normal BMI between 18.5 and 35

Disqualifiers

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.

Trial population

Our study population pertains to female patients and volunteers, of the age between 18 years old and 40 years old, with a regular menstrual cycle (25-35 days) and a normal BMI (18.5-35). You are eligible if you have not used any form of hormonal contraception or copper IUD throughout the last 3 months, have not had an ovarian stimulation during this time period, and are not known with renal or cardiac disease, diabetes or hypertension.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood samples for the analysis of biomarkers.

    Diagnostic test

    We will collect several blood samples: * One at day 8 of the cycle: measurements of P, E2, Na, K, CL, CO2, Osmolality, PRL, direct renin, PAC, Nt-proBNP, Relaxin-2 and VEGF. * One for cycle follow up between day 8 and ovulation: measurement of P, E2, LH * One at day 7 after ovulation induction: measurements of P, E2, Na, K, CL, CO2, Osmolality, PRL, direct renin, PAC, Nt-proBNP, Relaxin-2 and VEGF.

  • Transvaginal ultrasound for follicle and endometrium measurements.

    Diagnostic test

    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.

  • Mean Arterial Pressure measurement.

    Diagnostic test

    The MAP will be measured at cycle day 7 and 7 days post-ovulation induction to follow cardiovascular adaptations.

  • Ovitrelle injection for ovulation induction

    Drug

    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.

Treatment groups

118 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Group A: Follicle size 11mm4 interventions
Group B: Follicle size 12 mm4 interventions
Group C: Follicle size 13 mm4 interventions
Group D: Follicle size 14 mm4 interventions
Group E: Follicle size 15 mm4 interventions
Group F: Follicle size 16 mm4 interventions
Group G: Follicle size 17 mm4 interventions
Group H: Follicle size 18 mm4 interventions

Trial outcomes

Primary outcomes

1

The relationship between progesterone levels and different follicular sizes on day 7 post ovulation induction.

Progesterone levels will be measured 7 days after ovulation induction to relate them to different follicular sizes.

Time frame
From the start of the menstrual cycle until 7 days after ovulation induction.

Secondary outcomes

1

Estradiol evolution throughout the cycle and its relation to luteal progesterone levels.

We will measure the estradiol on different moments throught the menstural cycle, and see how these levels correspond to later (luteal) progesterone levels.

Time frame
From the start of a menstrual cycle until 7 days post-ovulation induction.
2

Indirect factors reflecting cardiovascular and renal adaptation in the luteal phase

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.

Time frame
From the start of the menstrual cycle until 7 days after ovulation induction.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitair Ziekenhuis Brussel

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: