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

Completed

• Conditions: Infertility, Female; Infertility; IVF; hCG
• Interventions: Drug: hCG; Diagnostic Test: Ultrasound; Other: Blood test

• Registration Number: NCT04417569
• Lead Sponsor: ART Fertility Clinics LLC

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.

Study Timeline

• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-04
• Study Start: 2021-02-04
• Primary Completion: 2021-05-26
• Study Completion: 2021-06-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-17
• Last Update Posted: 2022-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
stimulated cycles	Ultrasound	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
stimulated cycles	Blood test	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
stimulated cycles	hCG	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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Level of progesterone day of egg retrieval	1 day	36hrs after trigger

Trial Locations

Locations (1)

ART Fertility Clinics LLC; 🇦🇪 Abu Dhabi, United Arab Emirates