Luteal PhaseNCT04693624
Early Luteal Hormones and IVF Outcomes After hCG Triggering
An observational study of Luteal Phase and in Vitro Fertilisation, run by Mỹ Đức Hospital at 1 site in Vietnam.
Trial summary
It has recently been demonstrated that a bolus trigger of hCG induces various unphysiological conditions in the early luteal phase that may negatively affect an IVF treatment cycle's reproductive outcome. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Luteal Phase, in Vitro Fertilisation
- What is being tested?
- Hormonal levels
- Type of treatment
- Injection or infusion
- How many people
- 95 participants
- Where
- 1 siteVietnam
- Study dates
- 12 Jan 2021to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- No healthy volunteers
- Adult
Study population: Vietnamese women who will be indicated for IVF treatment with hCG administration for final oocytes maturation and undergo fresh embryo transfers.
Who may be able to join
- Age 18 - 38
- BMI < 28kg/m2
- Normal ovarian reserve (anti-Müllerian hormone level above 8.93 pmol/L or an antral follicle count of 6 or above within two months prior to stimulation)
- Having 4 to 19 follicles with a diameter of 14mm or above on the day of hCG triggering
- Receiving a standard GnRH-antagonist protocol for ovarian stimulation
- Having indication for fresh embryo transfer
- Willingness to participate in the study, and to disclose any medical conditions to the investigator. The patient must be prepared and willing to comply with the requirements of the protocol.
- The patient should after appropriate oral and written consent understand the study and be informed that she may withdraw consent at any time without prejudice to future medical care.
Who cannot join
- Previous poor ovarian response (≤ 3 follicles) after appropriate FSH stimulation
- Hyper-response defined as ≥20 follicles ≥14 mm on the day of trigger
- Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis B, Sexually Transmitted Diseases and simultaneous participation in an interventional clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reproductive Outcome of IVF Treatment in Relation to the Early Luteal Phase Trajectory of Progesterone and Other Corpus Luteum Related Hormones
It has recently been demonstrated that a bolus trigger of hCG induces various unphysiological conditions in the early luteal phase that may negatively affect an IVF treatment cycle's reproductive outcome. The bolus trigger of hCG differ from the natural cycle in mainly three different ways: 1) The timing of the initiation of hCG and progesterone rise is much faster after an hCG trigger than in the natural menstrual cycle 2) the maximal concentrations of hCG and progesterone considerably exceed those naturally observed 3) The timing of the peak progesterone concentration following an hCG trigger is advanced several days compared to the natural cycle. These characteristics may affect the reproductive outcome in treatment cycles but are not explored. The aim of this study is to monitor whether specific trajectories of important luteal phase hormones may predict the chances of conception?
Read the detailed description
The early luteal phase after ovarian stimulation and final oocyte maturation using a bolus trigger of hCG is an area that has not received the same attention as regimes and protocols for ovarian stimulation during the follicular phase. The hCG trigger has been considered the golden standard since the beginning of the IVF era almost four decades ago. The hCG trigger serves two main functions: 1) it induces oocytes to advance meiosis to the metaphase of the second meiotic division ready for fertilization and further development, 2) secures stimulation of the corpora lutea to secrete progesterone (P4) during the early luteal phase due to its relatively long half-life. However, recent studies have suggested that each of these two functions may be optimized on their own and that better alternatives to the hCG trigger may be developed including a more physiological trigger for final maturation of follicles and individualized luteal phase support. However, only recently has the early luteal phase after IVF treatment using an hCG bolus trigger been described in studies involving more than just a few patients. These studies suggested that the unphysiological effects of the hCG trigger may be divided into three different categories: 1) The timing of the initiation of hCG and progesterone rise is much faster after an hCG trigger than in the natural menstrual cycle 2) the maximal concentrations of hCG and progesterone considerably exceed those naturally observed 3) The timing of the peak progesterone concentration following an hCG trigger is advanced several days compared to the natural cycle. How each of these effects influences pregnancy outcome in treatment cycles are currently unknown. Further, does characteristics shortly after administration of the hCG trigger for final oocyte maturation subsequently affect the reproductive outcome, and does this provide an opportunity for correcting or improving the luteal phase support given, with the improvement of clinical pregnancy rate as a result is also unknown. The aim of this study is to evaluate the trajectories of four hormones important for corpora lutea function (i.e. P4, 17-OH-P4, hCG, and inhibin-A) during the early luteal phase in women undergoing IVF treatment with luteal phase support given in the form of exogenous P4 administration and evaluate whether clinical pregnancy rates are related to specific characteristics of the early luteal phase. By including the measurements of 17-OH-P4 and inhibin-A the study will obtain an evaluation of the function of corpora lutea itself independent of the P4 administration provided.
- Conditions
- Luteal Phase, in Vitro Fertilisation
- Being tested
- Hormonal levels
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormonal levelsOther
A total of ten (10) blood samples (2ml/each) will be collected during the study for subsequent analysis of progesterone, hCG, inhibin-A, and 17-OH-progesterone:
Day of triggering (before the injection of hCG, appx. 6 pm) Twelve (12 hours) after hCG injection (appx. at 6 am) Twenty-four (24) hours after hCG injection (appx. at 6 pm) Thirty-six (36) hours after hCG injection (appx. at 8 am, 2 hours after OPU) One (1) day after OPU (60h after hCG) (appx. at 6 am) Two (2) days after OPU (84h after hCG) (appx. at 6 am) Three (3) days after OPU 108h after hCG) (appx. at 6 am) Four (4) days after OPU (132h after hCG) (appx. at 6 am) Five (5) days after OPU (156h after hCG) (appx. at 6 am) Six (6) days after OPU (180h after hCG) (appx. at 6 am)
| Study group | Role | What they receive |
|---|---|---|
| Hormonal levels | Blood samples are collected for analysis of progesterone, hCG, inhibin-A, and 17-OH-Progesterone levels. Receives: Other: Hormonal levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate in relation to the trajectory of progesterone in the early luteal phase
Live birth was defined as the birth of at least one newborn after 24 weeks' gestation that exhibited any sign of life (twins were a single count).
Measured: After 24 weeks of gestation
Live birth rate in relation to the trajectory of 17-OH progesterone in the early luteal phase
Live birth was defined as the birth of at least one newborn after 24 weeks' gestation that exhibited any sign of life (twins were a single count).
Measured: After 24 weeks of gestation
Live birth rate in relation to the trajectory of hCG in the early luteal phase
Live birth was defined as the birth of at least one newborn after 24 weeks' gestation that exhibited any sign of life (twins were a single count).
Measured: After 24 weeks of gestation
Secondary outcomes (7)
The clinical pregnancy rate in relation to the trajectory of progesterone in the early luteal phase
Pregnancy with at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity
Measured: At 5 weeks after embryo placement
The ongoing pregnancy rate in relation to the trajectory of progesterone in the early luteal phase
Pregnancy with detectable heart rate at 12 weeks' gestation or beyond
Measured: At 10 weeks or beyond after the embryo placement
The clinical pregnancy rate in relation to the trajectory of 17-OH progesterone in the early luteal phase
Pregnancy with at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity
Measured: At 5 weeks after embryo placement
The ongoing pregnancy rate in relation to the trajectory of 17-OH progesterone in the early luteal phase
Pregnancy with detectable heart rate at 12 weeks' gestation or beyond
Measured: At 10 weeks or beyond after the embryo placement
The miscarriage rate in relation to the trajectory of progesterone in the early luteal phase
Pregnancy loss before 12 completed weeks of gestational age
Measured: Before 12 weeks of gestation
The miscarriage rate in relation to the trajectory of 17-OH progesterone in the early luteal phase
Pregnancy loss before 12 completed weeks of gestational age
Measured: Before 12 weeks of gestation
Live birth rate in relation to the trajectory of inhibin A in the early luteal phase
Will be reported in a separate paper
Measured: After 24 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start12 Jan 2021
- Primary completion30 Aug 2022
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Luteal PhaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mỹ Đức Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan N Vuong, PhD, Principal investigator, Mỹ Đức Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693624
- Sponsor's protocol ID
- 18/20/DD-BV
- Status last verified
- Jun 2023
- First submitted
- 28 Dec 2020
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
N Vuong L, D Pham T, N A Ho V, T L Vu A, M Ho T, Yding Andersen C. In vitro fertilization outcome based on the detailed early luteal phase trajectory of hormones: a prospective cohort study. Reprod Biol Endocrinol. 2024 May 20;22(1):56. doi: 10.1186/s12958-024-01229-3.
PubMed 38769552
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproductive Outcome of IVF Treatment in Relation to the Early Luteal Phase Trajectory of Progesterone and Other Corpus Luteum Related Hormones
- ClinicalTrials.gov ID
- NCT04693624
- Acronym / sponsor ID
- 18/20/DD-BV
- Conditions
- Luteal Phase, in Vitro Fertilisation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Mỹ Đức HospitalUniversity, hospital or other
- Study start
- 12 Jan 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 5 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It has recently been demonstrated that a bolus trigger of hCG induces various unphysiological conditions in the early luteal phase that may negatively affect an IVF treatment cycle's reproductive outcome. The bolus trigger of hCG differ from the natural cycle in mainly three different ways: 1) The timing of the initiation of hCG and progesterone rise is much faster after an hCG trigger than in the natural menstrual cycle 2) the maximal concentrations of hCG and progesterone considerably exceed those naturally observed 3) The timing of the peak progesterone concentration following an hCG trigger is advanced several days compared to the natural cycle. These characteristics may affect the reproductive outcome in treatment cycles but are not explored. The aim of this study is to monitor whether specific trajectories of important luteal phase hormones may predict the chances of conception?
Detailed description
The early luteal phase after ovarian stimulation and final oocyte maturation using a bolus trigger of hCG is an area that has not received the same attention as regimes and protocols for ovarian stimulation during the follicular phase. The hCG trigger has been considered the golden standard since the beginning of the IVF era almost four decades ago. The hCG trigger serves two main functions: 1) it induces oocytes to advance meiosis to the metaphase of the second meiotic division ready for fertilization and further development, 2) secures stimulation of the corpora lutea to secrete progesterone (P4) during the early luteal phase due to its relatively long half-life. However, recent studies have suggested that each of these two functions may be optimized on their own and that better alternatives to the hCG trigger may be developed including a more physiological trigger for final maturation of follicles and individualized luteal phase support. However, only recently has the early luteal phase after IVF treatment using an hCG bolus trigger been described in studies involving more than just a few patients. These studies suggested that the unphysiological effects of the hCG trigger may be divided into three different categories: 1) The timing of the initiation of hCG and progesterone rise is much faster after an hCG trigger than in the natural menstrual cycle 2) the maximal concentrations of hCG and progesterone considerably exceed those naturally observed 3) The timing of the peak progesterone concentration following an hCG trigger is advanced several days compared to the natural cycle. How each of these effects influences pregnancy outcome in treatment cycles are currently unknown. Further, does characteristics shortly after administration of the hCG trigger for final oocyte maturation subsequently affect the reproductive outcome, and does this provide an opportunity for correcting or improving the luteal phase support given, with the improvement of clinical pregnancy rate as a result is also unknown. The aim of this study is to evaluate the trajectories of four hormones important for corpora lutea function (i.e. P4, 17-OH-P4, hCG, and inhibin-A) during the early luteal phase in women undergoing IVF treatment with luteal phase support given in the form of exogenous P4 administration and evaluate whether clinical pregnancy rates are related to specific characteristics of the early luteal phase. By including the measurements of 17-OH-P4 and inhibin-A the study will obtain an evaluation of the function of corpora lutea itself independent of the P4 administration provided.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hormonal levels | – | Other: Hormonal levelsBlood samples are collected for analysis of progesterone, hCG, inhibin-A, and 17-OH-Progesterone levels. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Vietnamese women who will be indicated for IVF treatment with hCG administration for final oocytes maturation and undergo fresh embryo transfers.
Key inclusion criteria (8 listed)
- Age 18 - 38
- BMI < 28kg/m2
- Normal ovarian reserve (anti-Müllerian hormone level above 8.93 pmol/L or an antral follicle count of 6 or above within two months prior to stimulation)
- Having 4 to 19 follicles with a diameter of 14mm or above on the day of hCG triggering
- Receiving a standard GnRH-antagonist protocol for ovarian stimulation
Key exclusion criteria (3 listed)
- Previous poor ovarian response (≤ 3 follicles) after appropriate FSH stimulation
- Hyper-response defined as ≥20 follicles ≥14 mm on the day of trigger
- Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis B, Sexually Transmitted Diseases and simultaneous participation in an interventional clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hormonal levelsA total of ten (10) blood samples (2ml/each) will be collected during the study for subsequent analysis of progesterone, hCG, inhibin-A, and 17-OH-progesterone: Day of triggering (before the injection of hCG, appx. 6 pm) Twelve (12 hours) after hCG injection (appx. at 6 am) Twenty-four (24) hours after hCG injection (appx. at 6 pm) Thirty-six (36) hours after hCG injection (appx. at 8 am, 2 hours after OPU) One (1) day after OPU (60h after hCG) (appx. at 6 am) Two (2) days after OPU (84h after hCG) (appx. at 6 am) Three (3) days after OPU 108h after hCG) (appx. at 6 am) Four (4) days after OPU (132h after hCG) (appx. at 6 am) Five (5) days after OPU (156h after hCG) (appx. at 6 am) Six (6) days after OPU (180h after hCG) (appx. at 6 am) | Other | Hormonal levels |
Primary outcome
Live birth rate in relation to the trajectory of progesterone in the early luteal phase
Time frame: After 24 weeks of gestation
Live birth was defined as the birth of at least one newborn after 24 weeks' gestation that exhibited any sign of life (twins were a single count).
Live birth rate in relation to the trajectory of 17-OH progesterone in the early luteal phase
Time frame: After 24 weeks of gestation
Live birth was defined as the birth of at least one newborn after 24 weeks' gestation that exhibited any sign of life (twins were a single count).
Live birth rate in relation to the trajectory of hCG in the early luteal phase
Time frame: After 24 weeks of gestation
Live birth was defined as the birth of at least one newborn after 24 weeks' gestation that exhibited any sign of life (twins were a single count).
7 secondary outcomes
The clinical pregnancy rate in relation to the trajectory of progesterone in the early luteal phase
Time frame: At 5 weeks after embryo placement
The ongoing pregnancy rate in relation to the trajectory of progesterone in the early luteal phase
Time frame: At 10 weeks or beyond after the embryo placement
The clinical pregnancy rate in relation to the trajectory of 17-OH progesterone in the early luteal phase
Time frame: At 5 weeks after embryo placement
The ongoing pregnancy rate in relation to the trajectory of 17-OH progesterone in the early luteal phase
Time frame: At 10 weeks or beyond after the embryo placement
The miscarriage rate in relation to the trajectory of progesterone in the early luteal phase
Time frame: Before 12 weeks of gestation
The miscarriage rate in relation to the trajectory of 17-OH progesterone in the early luteal phase
Time frame: Before 12 weeks of gestation
Live birth rate in relation to the trajectory of inhibin A in the early luteal phase
Time frame: After 24 weeks of gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- Derived from this study: PubMed 38769552N Vuong L, D Pham T, N A Ho V, T L Vu A, M Ho T, Yding Andersen C. In vitro fertilization outcome based on the detailed early luteal phase trajectory of hormones: a prospective cohort study. Reprod Biol Endocrinol. 2024 May 20;22(1):56. doi: 10.1186/s12958-024-01229-3.
- Individual participant dataSharing planned: No
Related trials for Luteal Phase
Recruiting
Protein Supplementation During Luteal Phase to Stop Protein Degradation
Muscle Atrophy
RecruitingPhase 1
First in Human Safety and Ease of Use Assessment of 400mg Progesterone Callavid in Women With Luteal Phase Insufficiency
Luteal Phase Insuffiency, Progesterone Delivery
RecruitingPhase 4
Progesterone Supplementation After Letrozole-stimulated Insemination
Infertility
RecruitingObservational study
Impact of IVF Hormonal Therapy on Endometrial Receptivity and Endometrial Senescent Cell Pathological Accumulation
Endometrial Receptivity
Not yet recruitingObservational study
The SPARK-PMDD Study
Premenstrual Dysphoric Disorder, PMDD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lan N Vuong, PhD principal investigator
Mỹ Đức Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Luteal Phase and in Vitro Fertilisation, run by Mỹ Đức Hospital at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate in relation to the trajectory of progesterone in the early luteal phase (time frame: After 24 weeks of gestation). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04693624, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.