Early Luteal Progesterone Profile After hCG Triggering

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Other: blood collection

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: hormonal levels; Blood samples are collected for analysis of LH, E2, hCG and progesterone.	Other: blood collection; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in serum concentrations of progesterone	Blood samples are collected at ten points of time.	in 6 days after human chorionic gonadotropin injection
change in serum concentrations of luteinizing hormone	Blood samples are collected at ten points of time.	in 6 days after hCG injection
change in serum concentrations of estradiol	Blood samples are collected at ten points of time.	in 6 days after hCG injection
change in serum concentrations of hCG	Blood samples are collected at ten points of time.	in 6 days after hCG injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of follicles larger than 11 millimeters	Number of follicles are counted on ultrasound image.	on the day of hCG injection

Collaborators and Investigators

• Sponsor: Vietnam National University
• Collaborators: Mỹ Đức Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): April 11, 2017

Study Registration Dates

• First Submitted: June 5, 2016
• First Submitted That Met QC Criteria: June 8, 2016
• First Posted (Estimate): June 14, 2016

Study Record Updates

• Last Update Posted (Actual): April 18, 2017
• Last Update Submitted That Met QC Criteria: April 17, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: in-vitro fertilization; luteal phase
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: NCKH/CGRH -01-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO