Early Luteal Hormones and IVF Outcomes After hCG Triggering

June 30, 2023 updated by: Mỹ Đức Hospital

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
    • Tan Binh
      • Ho Chi Minh City, Tan Binh, Vietnam
        • Mỹ Đức Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Vietnamese women who will be indicated for IVF treatment with hCG administration for final oocytes maturation and undergo fresh embryo transfers.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Hormonal levels
Blood samples are collected for analysis of progesterone, hCG, inhibin-A, and 17-OH-Progesterone levels.
Other: Hormonal levels

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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
After 24 weeks of gestation
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).
After 24 weeks of gestation
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).
After 24 weeks of gestation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The clinical pregnancy rate in relation to the trajectory of progesterone in the early luteal phase
Time Frame: At 5 weeks after embryo placement
Pregnancy with at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity
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
Pregnancy with detectable heart rate at 12 weeks' gestation or beyond
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
Pregnancy with at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity
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
Pregnancy with detectable heart rate at 12 weeks' gestation or beyond
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
Pregnancy loss before 12 completed weeks of gestational age
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
Pregnancy loss before 12 completed weeks of gestational age
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
Will be reported in a separate paper
After 24 weeks of gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mỹ Đức Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lan N Vuong, PhD, Mỹ Đức Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 28, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18/20/DD-BV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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