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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| 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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| Follicle size 13 mm | Patients with a follicle of 13mm when measured through transvaginal ultrasound in 2D, at time of ovulation induction. |
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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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples for the analysis of biomarkers. | Diagnostic Test | We will collect several blood samples:
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the start of the menstrual cycle until 7 days after ovulation induction. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the start of a menstrual cycle until 7 days post-ovulation induction. |
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Inclusion Criteria:
Exclusion Criteria:
Our study can only include people who have a menstrual cycle, as this is needed for our measurements and is our specific study 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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Roelens | Contact | 0032 2 477 9887 | caroline.roelens@uzbrussel.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Jette | 1090 | Belgium |
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Blood samples.
| Follicle size 15 mm | Patients with a follicle of 15mm when measured through transvaginal ultrasound in 2D, at time of ovulation induction. |
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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. |
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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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| Follicle size 18 mm | Patients with a follicle of 18mm when measured through transvaginal ultrasound in 2D, at time of ovulation induction. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
| From the start of the menstrual cycle until 7 days after ovulation induction. |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D006063 | Chorionic Gonadotropin |
| D010062 | Ovulation Induction |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010926 | Placental Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011257 | Pregnancy Proteins |
| D011506 | Proteins |
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
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