Corpus Luteum Function and Cardiovascular Adaptation in a Natural MOCK Cycle. (CLEAR)
2026年6月9日 更新者：Noa Wauters、Universitair Ziekenhuis Brussel
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.
研究概览
地位
尚未招聘
研究类型
观察性的
注册 (估计的)
118
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Caroline Roelens
- 电话号码：0032 2 477 9887
- 邮箱：caroline.roelens@uzbrussel.be
学习地点
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-
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Jette、比利时、1090
- UZ Brussel
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接触：
- Caroline Roelens
- 电话号码：0032 2 477 9887
- 邮箱：caroline.roelens@uzbrussel.be
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
取样方法
概率样本
研究人群
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.
描述
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).
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Follicle size 11mm
Patients with a follicle of 11mm 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.
|
|
Follicle size 12 mm
Patients with a follicle of 12mm 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.
|
|
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.
|
|
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.
|
|
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.
|
|
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.
|
|
Follicle size 17 mm
Patients with a follicle of 17mm 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.
|
|
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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The relationship between progesterone levels and different follicular sizes on day 7 post ovulation induction.
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Estradiol evolution throughout the cycle and its relation to luteal progesterone levels.
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年7月1日
初级完成 (估计的)
2028年2月1日
研究完成 (估计的)
2028年9月1日
研究注册日期
首次提交
2026年6月9日
首先提交符合 QC 标准的
2026年6月9日
首次发布 (实际的)
2026年6月15日
研究记录更新
最后更新发布 (实际的)
2026年6月15日
上次提交的符合 QC 标准的更新
2026年6月9日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.