Corpus Luteum Function and Cardiovascular Adaptation in a Natural MOCK Cycle. (CLEAR)
2026년 6월 9일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
연구 유형
관찰
등록 (추정된)
118
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Caroline Roelens
- 전화번호: 0032 2 477 9887
- 이메일: caroline.roelens@uzbrussel.be
연구 장소
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Jette, 벨기에, 1090
- UZ Brussel
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연락하다:
- Caroline Roelens
- 전화번호: 0032 2 477 9887
- 이메일: caroline.roelens@uzbrussel.be
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
샘플링 방법
확률 샘플
연구 인구
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.
설명
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).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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.
|
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.
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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 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.
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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 16 mm
Patients with a follicle of 16mm 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 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The relationship between progesterone levels and different follicular sizes on day 7 post ovulation induction.
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Estradiol evolution throughout the cycle and its relation to luteal progesterone levels.
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2028년 2월 1일
연구 완료 (추정된)
2028년 9월 1일
연구 등록 날짜
최초 제출
2026년 6월 9일
QC 기준을 충족하는 최초 제출
2026년 6월 9일
처음 게시됨 (실제)
2026년 6월 15일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 9일
마지막으로 확인됨
2026년 6월 1일
추가 정보
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