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Early Luteal Progesterone Profile in IVF Patients Triggered With hCG

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ClinicalTrials.gov Identifier: NCT03174691
Recruitment Status : Completed
First Posted : June 2, 2017
Last Update Posted : August 18, 2017
Sponsor:
Collaborator:
Mỹ Đức Hospital
Information provided by (Responsible Party):
Manh Tuong Ho, Vietnam National University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Infertility Diagnostic Test: Blood collection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Intervention Model: Single Group Assignment
Intervention Model Description: IVF patients triggered with hCG
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Early Luteal Progesterone Profile in IVF Patients Triggered With hCG
Actual Study Start Date : June 7, 2017
Actual Primary Completion Date : August 8, 2017
Actual Study Completion Date : August 8, 2017

Resource links provided by the National Library of Medicine


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.





Primary Outcome Measures :
  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 Outcome Measures :
  1. Number of follicles ≥ 11 mm luteal phase [ Time Frame: On the day of hCG injection ]
    Number of follicles are counted by ultrasound.



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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174691


Locations
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Vietnam
My Duc Hospital
Ho Chi Minh City, Vietnam, 70000
Sponsors and Collaborators
Vietnam National University
Mỹ Đức Hospital
Investigators
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Principal Investigator: Tuong M Ho, MD Research Center for Genetics and Reproductive Health Ho Chi Minh, Ho Chi Minh Vietnam

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Responsible Party: Manh Tuong Ho, Doctor, Vietnam National University
ClinicalTrials.gov Identifier: NCT03174691     History of Changes
Other Study ID Numbers: NCKH/CGRH-09-2017
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs