Clincosm LogoSign in Get a demo

A Proof of Concept Study of Serum Progesterone Levels for IVF/ICSI Following HCG Trigger for Oocyte Maturation

Sponsor
ART Fertility Clinics LLC (Other)
Overall Status
Completed
CT.gov ID
NCT04417569
Collaborator
(none)
10
Enrollment
1
Location
4.8
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will determine the rise of progesterone levels after human chorionic gonadotrophin (hCG) trigger in stimulated cycles IVF/ICSI

Condition or Disease Intervention/Treatment Phase
  • Drug: hCG
  • Diagnostic Test: Ultrasound
  • Other: Blood test

Detailed Description

Studies have suggested that controlled ovarian hyperstimulation adversely affects endometrial receptivity. In ovarian stimulation cycles with exogenous gonadotrophins there is an ongoing debate regarding the effect of a late follicular phase progesterone level on reproductive outcomes. It is not yet clarified if an elevated serum progesterone level in the late follicular phase is a symptom or cause of an adverse effect on reproductive outcomes. A new hypothesis is evolving and gaining momentum providing a novel explanation for the association between late follicular phase progesterone rise and reproductive outcome. It is proposed that exogenous FSH (Follicle-stimulating hormone) administration results in supraphysiological levels of FSH, which induce an abundance of LH (luteinizing hormone) receptors on granulosa cells causing the follicles to become hypersensitive to LH-like activity (ie hCG trigger). Based on this hypothesis, the focus should be placed on the hCG trigger rather than on the late follicular phase progesterone rise.

Study Design

Study Type:
Observational
Actual Enrollment :
10 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
A Proof of Concept Study to Determine the Rise of Progesterone Levels After Human Chorionic Gonadotrophin (hCG) Trigger in Stimulated Cycles of IVF/ICSI
Actual Study Start Date :
Feb 4, 2021
Actual Primary Completion Date :
May 26, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
stimulated cycles

Patients will have blood drawn on five separate occasions: before and following hCG trigger on the day of final oocyte maturation and day of egg collection

Drug: hCG
human chorionic gonadotropin
Other Names:
  • human chorionic gonadotropin

    • Diagnostic Test: Ultrasound
    Endometrial thickness monitoring
    Other Names:
  • transvaginal scan

    • Other: Blood test
    Progesterone, Luteinizing Hormone, Estradiol
    Other Names:
  • Progesterone, Luteinizing Hormone, Estradiol

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Level of progesterone day of trigger [1 day]

      day of the hCG trigger between 1000h - 1200h, before trigger, 1 hour after trigger, 2 hrs after trigger

    Secondary Outcome Measures

    1. Level of progesterone day of egg retrieval [1 day]

      36hrs after trigger

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 42 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Females aged 18 to 42 years with regular menstrual cycles of 26-34 days

    • Undergoing ovarian stimulation for IVF/ICSI & PGS.

    • Receiving recombinant FSH for stimulation

    • hCG 5000iu IM as trigger injection for oocyte maturation.

    • Ovarian stimulation in GnRH-antagonist protocols

    • BMI 18- 35 kg/m2

    • Having 1 or 2 euploid embryos for transfer in spontaneous natural cycles.

    Exclusion Criteria:

    • Poor ovarian reserve as defined by Bologna criteria

    • PCOS in accordance with Rotterdam criteria

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ART Fertility Clinics LLC Abu Dhabi United Arab Emirates 60202

    Sponsors and Collaborators

    • ART Fertility Clinics LLC

    Investigators

    • Principal Investigator: Raquel Loja Vitorino, Specialist, ART Fertility Clinics LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ART Fertility Clinics LLC
    ClinicalTrials.gov Identifier:
    NCT04417569
    Other Study ID Numbers:
    • 2002-ABU-001-CC
    First Posted:
    Jun 4, 2020
    Last Update Posted:
    Feb 18, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Infertility
    Infertility, Female
    Chorionic Gonadotropin
    Estradiol
    Progesterone

    Study Results

    No Results Posted as of Feb 18, 2022