Skip to main content
OpenTrials
Completed

NCT Number: NCT03174691

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

My Duc Hospital

Ho Chi Minh City, 70000, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood collection

Diagnostic Test

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.

Primary outcomes

  1. Serum concentrations of progesterone,17-Hydroxyprogesterone, LH, E2, and hCG during early luteal phase

    Time frame: In 6 days after human chorionic gonadotropin injection

    Blood samples are collected at ten points of time.

Secondary outcomes

  1. Number of follicles ≥ 11 mm luteal phase

    Time frame: On the day of hCG injection

    Number of follicles are counted by ultrasound.

Sponsors and collaborators

Lead sponsor

Vietnam National University

Other

Collaborators

  • Mỹ Đức Hospital

Registry information

Official study title

The Early Luteal Progesterone Profile in IVF Patients Triggered With hCG

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 2, 2017
Registry last updated
Aug 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.