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

ART Fertility Clinics LLC

Status: Completed

Conditions: IVF; Infertility; hCG; Infertility, Female

Treatments: Other: Blood test; Diagnostic Test: Ultrasound; Drug: hCG

Study type: Observational

Funder types: Other

Identifiers

NCT04417569

2002-ABU-001-CC

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 42 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

10 participants in 1 patient group

stimulated cycles

Description:

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

Treatment:

Drug: hCG

Diagnostic Test: Ultrasound

Other: Blood test