The aim of this trial is to examine the possible effects of hCG administration for eight weeks prior to IVF/ICSI in women with low ovarian reserve. Primary outcome is the proportion of the antral follicle count that reach the pre-ovulatory stage.
One of the fundamental goals in In Vitro Fertilisation (IVF) is obtaining a high number of good quality oocytes, in order to select and transfer embryos with the highest possible implantation potential thereby optimizing the chance of a pregnancy and ultimately a live birth. This is done by applying an individualized controlled ovarian stimulation (iCOS) protocol, primarily based on ovarian reserve markers like antral follicle count (AFC) and Anti-Müllerian hormone (AMH), when deciding the follicle stimulating hormone (FSH) stimulation dose. Certain patients, the so called "poor ovarian responders' (PORs), pose a clinical challenge because they have a poor ovarian reserve and develop a limited number of pre-ovulatory follicles in respond to ovarian stimulation despite high FSH stimulation doses, thus experiencing reduced live birth rates. The aim of the present study is to examine the possible effects of long-term LH activity by the administration of hCG for eight weeks in between two identical IVF/ICSI cycles and compare cycle characteristics and outcome. The primary outcome is the follicular output rate (FORT) which reflects the proportion of antral follicles at the start of controlled ovarian stimulation that reaches the pre-ovulatory state. Secondary outcomes include amongst others AMH and antral follicle count at baseline (cd 2-3), number of pre-ovulatory follicles, oocytes retrieved, and embryos developed. We hypothesize that eight weeks of androgen priming by hCG increases the proportion of antral follicles that reaches the pre-ovulatory state during controlled ovarian stimulation for IVF/ICSI in women with poor ovarian reserve.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Ovitrelle 260 IE once daily for 8 weeks prior to IVF/ICSI
Rigshospitalet
København Ø, Denmark
Follicular output rate
Follicular Output Rate (FORT: pre-ovulatory follicle count (\>16 mm) at hCG trigger day/antral follicle count at baseline (2-10 mm).
Time frame: Through study completion, an average of 5 months
Antral follicle count (≤10 mm) at baseline (cd 2-3)
Time frame: Through study completion, an average of 5 months
AMH at baseline (CD 2-3)
Time frame: Through study completion, an average of 5 months
Number of pre-ovulatory follicles >16 mm on trigger day
Time frame: Through study completion, an average of 5 months
Number of follicles >14 mm and >12 mm, >10 mm and ≤10 mm on hCG trigger day
Time frame: Through study completion, an average of 5 months
Number of oocytes retrieved
Time frame: Through study completion, an average of 5 months
Number of mature (MII) oocytes
Time frame: Through study completion, an average of 5 months
Number of fertilized eggs (2pn)
Time frame: Through study completion, an average of 5 months
Number of cleaved day 2 embryos
Time frame: Through study completion, an average of 5 months
Number of good quality day 2 embryos
Time frame: Through study completion, an average of 5 months
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Number of top quality day 2 embryos
Time frame: Through study completion, an average of 5 months
Number of blastocysts (Gardner score 1-6)
Time frame: Through study completion, an average of 5 months
Number of good quality blastocysts day 5/6
Time frame: Through study completion, an average of 5 months
Number of vitrified embryos/blastocysts
Time frame: Through study completion, an average of 5 months
Total number of transferred or vitrified blastocysts
Time frame: Through study completion, an average of 5 months
The number of cancelled cycles and the reasons for cancellation in the two groups
Time frame: Through study completion, an average of 5 months
Serum and follicular fluid hormonal levels (AMH, estradiol, progesterone, 17-OH-progesterone, hCG, LH, FSH, testosterone, androstenedione and Inhibin B
Time frame: Through study completion, an average of 5 months
Granulosa/cumulus cell FSH and LH receptor expression
Time frame: 1 year
Cumulus/corona gene expression analysis by quantitative PCR using three predictive genes (EFNB2, SASH1, CAMK1D).
Time frame: 1 year