Clinical trial NCT02798146: Early Luteal Progesterone Profile After hCG Triggering
Official title: The Early Luteal Progesterone Profile in IVF Patients Triggered With hCG - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: in-vitro fertilization
luteal phase
Lead sponsor: Vietnam National University
Sponsor class: OTHER
Collaborators: name: Mỹ Đức Hospital
First posted: 2016-06-14
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: change in serum concentrations of progesterone
timeFrame: in 6 days after human chorionic gonadotropin injection
measure: change in serum concentrations of luteinizing hormone
timeFrame: in 6 days after hCG injection
measure: change in serum concentrations of estradiol
timeFrame: in 6 days after hCG injection
measure: change in serum concentrations of hCG
timeFrame: in 6 days after hCG injection
Secondary outcomes:
measure: number of follicles larger than 11 millimeters
timeFrame: on the day of hCG injection
Other outcomes:
Locations:
Study officials:
References:
citation: 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.