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

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

Detailed Description
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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.

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

Conditions
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Infertility, Infertility, Female, IVF, hCG

Intervention / Treatment
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* Drug: hCG
* Diagnostic Test: Ultrasound
* Other: Blood test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| stimulated cycles<br>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 | Drug: hCG<br>* human chorionic gonadotropin<br>* Other names: human chorionic gonadotropin;Diagnostic Test: Ultrasound<br>* Endometrial thickness monitoring<br>* Other names: transvaginal scan;Other: Blood test<br>* Progesterone, Luteinizing Hormone, Estradiol<br>* Other names: Progesterone, Luteinizing Hormone, Estradiol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of progesterone day of trigger | day of the hCG trigger between 1000h - 1200h, before trigger, 1 hour after trigger, 2 hrs after trigger | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of progesterone day of egg retrieval | 36hrs after trigger | 1 day |