Early Luteal Progesterone Profile in IVF Patients Triggered With hCG

The Early Luteal Progesterone Profile in IVF Patients Triggered With hCG

Until now very little information exists regarding the early luteal serum progesterone profile after Human chorionic gonadotropin (hCG) trigger. This pilot study will help characterize the serum progesterone, 17-hydroxyprogesterone profiles in IVF patients and correlate progesterone, 17-Hydroxyprogesterone levels to ovarian follicles obtained after stimulation with exogenous gonadotropins.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Diagnostic test: Blood collection

Detailed Description

The early luteal phase after IVF treatment is only scarcely studied. During IVF treatment the early luteinizing hormone (LH) activity deficit induced after ovarian stimulation with exogenous gonadotropins will be partly covered by the bolus of hCG used for triggering of final oocyte maturation due to the long half-life of hCG. In addition, the luteal phase will be covered by exogenous progesterone supplementation. After successful implantation the embryo itself will provide the supportive LH activity, securing the function of the corpora lutea. However, during the early luteal phase and peri-implantation, recent data suggest that an early-mid-luteal hCG/LH deficiency exists after hCG trigger during which the corpus luteum lacks an optimal stimulation. Furthermore, 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, we wish to further explore the early luteal phase profiles of progesterone, 17-Hydroxyprogesterone and hCG in order to optimize current luteal phase support policies in IVF and hopefully increase ongoing pregnancy rates.

• Study Type: Interventional
• Enrollment (Actual): 161
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam, 70000
    • My Duc Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Freeze all cycle after hCG trigger
• Age 18 - 38
• 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 gonadotrophin releasing hormone (GnRH) 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 follicle stimulating hormone (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: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hormonal levels; Collect blood samples 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	Diagnostic test: Blood collection; A total of ten (10) blood samples (2ml/each) will be collected during the study. Blood samples will be collected on the following days for subsequent analysis of LH, Estradiol, hCG, progesterone and 17-Hydroxyprogesterone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum concentrations of progesterone,17-Hydroxyprogesterone, LH, E2, and hCG during early luteal phase	Blood samples are collected at ten points of time.	In 6 days after human chorionic gonadotropin injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of follicles ≥ 11 mm luteal phase	Number of follicles are counted by ultrasound.	On the day of hCG injection

Collaborators and Investigators

• Sponsor: Vietnam National University
• Collaborators: Mỹ Đức Hospital
• Investigators: Principal Investigator: Tuong M Ho, MD, Research Center for Genetics and Reproductive Health Ho Chi Minh, Ho Chi Minh Vietnam

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 (Actual): June 7, 2017
• Primary Completion (Actual): August 8, 2017
• Study Completion (Actual): August 8, 2017

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): August 6, 2019
• Last Update Submitted That Met QC Criteria: August 3, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: NCKH/CGRH-09-2017

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
• product manufactured in and exported from the U.S.: No