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

A Proof of Concept Study to Determine the Rise of Progesterone Levels After Human Chorionic Gonadotrophin (hCG) Trigger in Stimulated Cycles of IVF/ICSI

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04417569
Enrollment
10
Registered
2020-06-04
Start date
2021-02-04
Completion date
2021-06-30
Last updated
2022-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hCG, Infertility, Infertility, Female, IVF

Brief summary

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

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.

Interventions

DRUGhCG

human chorionic gonadotropin

DIAGNOSTIC_TESTUltrasound

Endometrial thickness monitoring

OTHERBlood test

Progesterone, Luteinizing Hormone, Estradiol

Sponsors

ART Fertility Clinics LLC
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 42 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Level of progesterone day of trigger1 dayday of the hCG trigger between 1000h - 1200h, before trigger, 1 hour after trigger, 2 hrs after trigger

Secondary

MeasureTime frameDescription
Level of progesterone day of egg retrieval1 day36hrs after trigger

Countries

United Arab Emirates

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026