InfertilityNCT02798146
Early Luteal Progesterone Profile After hCG Triggering
A study testing blood collection in people with Infertility, run by Vietnam National University.
Trial summary
This pilot-study will help characterize the serum progesterone profiles in IVF patients and correlate progesterone levels to ovarian follicles obtained after stimulation with exogenous gonadotropins. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- blood collection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to 11 Apr 2017
- Phase
- Interventional
- 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
Who may be able to join
- IVF patients who meet the following criteria:
- Freeze all cycle after hCG trigger
- Age 18 - 38
- Body Mass Index (BMI) < 28kg/m2
- Normal ovarian reserve, defined by Anti-Mullerian Hormone (AMH) > 1.25 ng/ml or Antral Follicle Count (AFC) ≥ 6 measured within two months prior to stimulation start
- Receiving Gonadotropin Releasing Hormone Antagonist co-treatment during ovarian stimulation
- Agreement to participate in the study, and to disclose any medical events to the investigator. The subject must be willing and able to comply with the protocol requirements for the duration of the study.
- Have given written informed consent with the understanding that the subject may withdraw consent at any time without prejudice to future medical care.
Who cannot join
- Previous poor response (≤ 3 oocytes) after high dose FSH stimulation
- Hyper-response defined as >20 follicles ≥ 14 mm
- Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis B and Sexually Transmitted Diseases Simultaneous participation in an interventional clinical trial.
About this study
Official title: The Early Luteal Progesterone Profile in IVF Patients Triggered With hCG - a Pilot Study
This pilot-study will help characterize the serum progesterone profiles in IVF patients and correlate progesterone levels to ovarian follicles obtained after stimulation with exogenous gonadotropins.
Read the detailed description
The early luteal progesterone profile in IVF differs significantly from the progesterone profile of the natural cycle, in which the peak is reached around the time of implantation. With this non-invasive trial investigators wish to further explore the early luteal phase profiles of progesterone and hCG in order to optimize current luteal phase support policies in IVF and hopefully increase ongoing pregnancy rates.
Stimulation, monitoring, and oocyte pick-up will be performed according to the standard procedure of the clinic. On the day of trigger with 5.000 IU hCG a blood sample will be drawn prior to triggering for subsequent analysis. Moreover, all ovarian follicles on each side equal to or above 11 mm will be registered. Oocyte pick-up and timing of the trigger bolus will be performed according to the standard procedures of the unit.
A total 10 blood samples will be drawn during this trial - please see "blood sampling". Blood samples will be collected on the following days for subsequent analysis of LH, E2, hCG and progesterone.
All embryos will be cryo-preserved for transfer in subsequent frozen/thaw embryo transfer cycles.
Primary endpoint Serum concentrations of progesterone, LH, E2, and hCG during early luteal phase.
Secondary endpoints The correlation between follicles ≥ 11 mm and progesterone in early luteal phase
Data are analyzed using SPSS version 20 software. All tests are two tailed, and P<0.05 is considered statistically significant. Continuous variables are presented as mean +/- SD and are tested by student's t-test. Categorical data are expressed as numbers and compared using the Chi-square test.
- Conditions
- Infertility
- Being tested
- blood collection
- Keywords
- in-vitro fertilization, luteal phase
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood collectionOther
Blood samples are collected on the following days after human chorionic gonadotropin (hCG) injection: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
| Study group | Role | What they receive |
|---|---|---|
| hormonal levels | Other | Blood samples are collected for analysis of LH, E2, hCG and progesterone. Receives: Other: blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in serum concentrations of progesterone
Blood samples are collected at ten points of time.
Measured: in 6 days after human chorionic gonadotropin injection
change in serum concentrations of luteinizing hormone
Blood samples are collected at ten points of time.
Measured: in 6 days after hCG injection
change in serum concentrations of estradiol
Blood samples are collected at ten points of time.
Measured: in 6 days after hCG injection
change in serum concentrations of hCG
Blood samples are collected at ten points of time.
Measured: in 6 days after hCG injection
Secondary outcomes (1)
number of follicles larger than 11 millimeters
Number of follicles are counted on ultrasound image.
Measured: on the day of hCG injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2016
- Study completion11 Apr 2017
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 InfertilityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vietnam National University
- Sponsor type
- University, hospital or other
- Collaborators
- Mỹ Đức Hospital
- Responsible party
- Principal investigator, Manh Tuong Ho, Vietnam National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798146
- Sponsor's protocol ID
- NCKH/CGRH -01-2016
- Status last verified
- Apr 2017
- First submitted
- 5 Jun 2016
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Vuong LN, Ho TM, Pham TD, Ho VNA, Andersen CY, Humaidan P. The early luteal hormonal profile in IVF patients triggered with hCG. Hum Reprod. 2020 Jan 1;35(1):157-166. doi: 10.1093/humrep/dez235.
PubMed 31967304
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Early Luteal Progesterone Profile in IVF Patients Triggered With hCG - a Pilot Study
- ClinicalTrials.gov ID
- NCT02798146
- Acronym / sponsor ID
- NCKH/CGRH -01-2016
- Conditions
- Infertility
- Keywords
- in-vitro fertilization, luteal phase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vietnam National UniversityUniversity, hospital or other
- Collaborators
- Mỹ Đức Hospital
- Study start
- Jun 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- 11 Apr 2017 (actual)
- First posted
- 14 Jun 2016 (estimated)
- 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.
This pilot-study will help characterize the serum progesterone profiles in IVF patients and correlate progesterone levels to ovarian follicles obtained after stimulation with exogenous gonadotropins.
Detailed description
The early luteal progesterone profile in IVF differs significantly from the progesterone profile of the natural cycle, in which the peak is reached around the time of implantation. With this non-invasive trial investigators wish to further explore the early luteal phase profiles of progesterone and hCG in order to optimize current luteal phase support policies in IVF and hopefully increase ongoing pregnancy rates.
Stimulation, monitoring, and oocyte pick-up will be performed according to the standard procedure of the clinic. On the day of trigger with 5.000 IU hCG a blood sample will be drawn prior to triggering for subsequent analysis. Moreover, all ovarian follicles on each side equal to or above 11 mm will be registered. Oocyte pick-up and timing of the trigger bolus will be performed according to the standard procedures of the unit.
A total 10 blood samples will be drawn during this trial - please see "blood sampling". Blood samples will be collected on the following days for subsequent analysis of LH, E2, hCG and progesterone.
All embryos will be cryo-preserved for transfer in subsequent frozen/thaw embryo transfer cycles.
Primary endpoint Serum concentrations of progesterone, LH, E2, and hCG during early luteal phase.
Secondary endpoints The correlation between follicles ≥ 11 mm and progesterone in early luteal phase
Data are analyzed using SPSS version 20 software. All tests are two tailed, and P<0.05 is considered statistically significant. Continuous variables are presented as mean +/- SD and are tested by student's t-test. Categorical data are expressed as numbers and compared using the Chi-square test.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hormonal levels | Other | Other: blood collectionBlood samples are collected for analysis of LH, E2, hCG and progesterone. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- IVF patients who meet the following criteria:
- Freeze all cycle after hCG trigger
- Age 18 - 38
- Body Mass Index (BMI) < 28kg/m2
- Normal ovarian reserve, defined by Anti-Mullerian Hormone (AMH) > 1.25 ng/ml or Antral Follicle Count (AFC) ≥ 6 measured within two months prior to stimulation start
Key exclusion criteria (3 listed)
- Previous poor response (≤ 3 oocytes) after high dose FSH stimulation
- Hyper-response defined as >20 follicles ≥ 14 mm
- Chronical medical conditions like Diabetes, Crohns disease, Thyroid disease, Hepatitis B and Sexually Transmitted Diseases 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 |
|---|---|---|
| blood collectionBlood samples are collected on the following days after human chorionic gonadotropin (hCG) injection: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6 | Other | hormonal levels |
Primary outcome
change in serum concentrations of progesterone
Time frame: in 6 days after human chorionic gonadotropin injection
Blood samples are collected at ten points of time.
change in serum concentrations of luteinizing hormone
Time frame: in 6 days after hCG injection
Blood samples are collected at ten points of time.
change in serum concentrations of estradiol
Time frame: in 6 days after hCG injection
Blood samples are collected at ten points of time.
change in serum concentrations of hCG
Time frame: in 6 days after hCG injection
Blood samples are collected at ten points of time.
1 secondary outcome
number of follicles larger than 11 millimeters
Time frame: on the day of hCG injection
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 18 Apr 2017.
- Derived from this study: PubMed 31967304Vuong LN, Ho TM, Pham TD, Ho VNA, Andersen CY, Humaidan P. The early luteal hormonal profile in IVF patients triggered with hCG. Hum Reprod. 2020 Jan 1;35(1):157-166. doi: 10.1093/humrep/dez235.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing blood collection in people with Infertility, run by Vietnam National University.
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 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
change in serum concentrations of progesterone (time frame: in 6 days after human chorionic gonadotropin injection). The study lists 4 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 NCT02798146, 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 18 Apr 2017.