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OpenTrials
Completed

NCT Number: NCT04417569

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

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

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Key information

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

ART Fertility Clinics LLC

Abu Dhabi, 60202, United Arab Emirates

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

HCG

Drug

human chorionic gonadotropin

Other names: human chorionic gonadotropin

Ultrasound

Diagnostic Test

Endometrial thickness monitoring

Other names: transvaginal scan

Blood Test

Other

Progesterone, Luteinizing Hormone, Estradiol

Other names: Progesterone, Luteinizing Hormone, Estradiol

Primary outcomes

  1. Level of progesterone day of trigger

    Time frame: 1 day

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

Secondary outcomes

  1. Level of progesterone day of egg retrieval

    Time frame: 1 day

    36hrs after trigger

Sponsors and collaborators

Lead sponsor

ART Fertility Clinics LLC

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 4, 2020
Registry last updated
Feb 18, 2022

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.

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