Clinical trial NCT04417569: A Proof of Concept Study of Serum Progesterone Levels for IVF/ICSI Following HCG Trigger for Oocyte Maturation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Infertility, Female
IVF
hCG
Lead sponsor: ART Fertility Clinics LLC
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients who are planned to commence ovarian stimulation for IVF/ICSI with hCG trigger for oocyte maturation and plan to avail of pre-implantation genetic screening with embryo vitrification of their biopsied embryos at blastocyst stage

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.

Eligibility criteria: 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

Primary outcomes:
measure: Level of progesterone day of trigger
timeFrame: 1 day
Secondary outcomes:
measure: Level of progesterone day of egg retrieval
timeFrame: 1 day
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: ART Fertility Clinics LLC
Study officials:
affiliation: ART Fertility Clinics LLC
name: Raquel Loja Vitorino, Specialist
role: PRINCIPAL_INVESTIGATOR
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