LH activity administration during the
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1 LH activity administration during the luteal-follicular transition Richard Fleming On behalf of the Luveris Pre-treatment group University of Glasgow Scotland
2 Androgens have a Paracrine action in the Early Follicular Phase LH (Hillier 2001) + FSH theca granulosa androgen Testosterone promotes aromatase expression in GCs (dose dependent) Testosterone promotes aromatase expression in GCs (dose dependent). LH promotes thecal androgen drive to the GCs
3 LH and Early Follicular Responses Primates treated with GnRH-Antagonist ZelinskyWootten Antide HCG 90 days r_hfsh r_hfsh + r_hlh Antide suppressed LH and E2 to levels seen in hypophysectomy r_hfsh Stimulation Days 12 Fertilized (%) 89 r_hfsh + r_hlh 9 52 Indications: 1. LH promotes improved early responses to FSH 2. LH has a negative impact in the peri-ovulatory period
4 Peri-menstrual transition: Study Aim Will LH administration, in the phase prior to FSH stimulation,,promote thecal drive to the GC of small antral follicles? and thereby: 1. promote more follicles to achieve appropriate p FSH sensitivity 2. improve oocyte quality by improving GC support for the oocyte
5 Study Design Cycle Day Day Day Day Day Gn15 Gn22 Gn29 HCG (Gn1) (L1) (S1) (S8) (SHCG) Depo Decapeptyl p (4.2mg) Downregulation check: Randomisation Response assessment Embryology # eggs, # 2PN embryos, # transferrable grade Luveris (300 IU/d, sc) (150 IU/ d, sc) Gonal F ( / d ) Dose adjustment
6 Demographics N Tubal Unxpl Male BMI FSH (%) (%) (%) (Kg/m 2 ) (IU/L) Control LH
7 Patient process Randomized Receiving HCG Control (n) 71 Luveris Pre-Tx (n) Cysts at downregulation - 2 OHSS Predicted d 1 1 Poor response 2 3 Premature luteinization i ti 1 1 Social / personal - 1 Violator (>FSH) 1 1 Total 5 9
8 LH Profiles No Pre-treatment LH Pre-treatment LH (IU/L) 6 4 P=0.01 P< L1 S1 S8 L1 S1 S8 Assessment stage
9 Changes during LH treatment Conversion of C 21 to C 19 (androgen) steroids 17αOH_Progesterone Testosterone No Pre-treatment LH Pre-treatment 2.0 P17 _ (ng/ml) 1.0 P=0.25 P=0.17 T. (ng/ml) 1.0 P=0.63 P= L1 S1 L1 S1 L1 S1 L1 S1 Assessment stage Assessment stage Between Groups: L1. p= 0.81 Between Groups: L1. p= 0.11 Between Groups: S1. p= 0.33 Between Groups: S1. p=
10 Changes during LH treatment Estradiol No Pre-treatment LH Pre-treatment P=0.29 P=0.82 E2 (pmol/l) L1 S1 L1 S1 Assessment stage Between Groups: L1. p= 0.15 Between Groups: S1. p= 0.14
11 Changes during LH treatment Anti-Mullerian Hormone No Pre-treatment LH Pre-treatment 100 *P=0.001 *P=0.001 *Paired t-test AMH (pmol/l) 50 0 L1 S1 L1 S1 Assessment stage Both groups showed an increase in AMH: 16% and 10%
12 Changes during LH treatment Antral follicle count No Pre-treatment LH Pre-treatment 15 P=0.45 P=0.007 AFC (n) L1 S1 L1 Assessment stage S1 Bt G L1 034 Between Groups: L1. p= 0.34 Between Groups: S1. p= 0.77
13 Changes during FSH treatment Demand for FSH FSH Days Total Dose Dose Increase Dose Decrease Control (55%) (4%) Luveris (55%) 3 (4%)
14 Changes during FSH treatment Follicle Profiles S8 SHCG 8 N FD 9-12mm FD >12 FD 9-14mm FD >15
15 Changes during FSH treatment Circulating Estradiol No Pre-treatment LH Pre-treatment Control Luveris E (pmol/l) S1 S8 HCG S1 S8 HCG Assessment stage
16 Changes during FSH treatment Estradiol: AUC & Per Follicle AUC E2 E2 per Follicle E2 (pmol) P = 0.43 E2 (pmol) P = 0.18 Control Luveris Control Luveris
17 After HCG Oocytes & Embryos Oocyte Yield (mean) PN2 Embryos (mean) Control Luveris P* (*Unpaired t-test: Welch s correction)
18 After HCG Embryology 12 P=0.096 *P=0.038 P=0.64 P=0.19 Mean (n) * Oocytes Fertilization Early Embryos (2PN) Cleavage High Grade
19 Discussion Pre-conditioning with Luveris treatment (300IU daily) prior to FSH stimulation of follicular l growth in normal women, resulted in some interesting observations. Associated with the increased LH activity recorded, we observed: Increased small antral follicle count (AFC) No change in circulating 17αOHprogesterone No change in circulating testosterone AMH showed an increase in both groups
20 Discussion During FSH treatment (following Luveris pre-treatment) there was: No difference in follicular sensitivity to FSH growth No modulation in the E2 responses to FSH A (non-significant) increase in oocyte yield ( g f ) y y A significant increase in embryo yield
21 Conclusion Pre-treatment t tof normal women undergoing ART with Luveris (300IU/d), altered the profile of follicular development prior to the start tof ffsht treatment. t t It had no discernible effect upon ovarian hormone secretions or apparent demand for FSH. Luveris pre-treatment significantly increased the yield of viable embryos (from an average of 5.1 to 7.0 per patient: 37%).
22 Lossl et al, H.R Intrafollicular androgens and recruitment Aim: to increase intrafollicular androgen concentrations before FSH recruitment Methods: 45 patients undergoing IVF, forming 3 groups treated prior to FSH injection Cycle Day 2 Cycle Day Cycle Day 5 8 Cetrotide (3mg) Groups 1, 2, 3 FSH + GnRH-Antag Letrozole (2.5mg/d) Groups 2, 3 FSH + GnRH-Antag HCG (1250IU) Group 3 FSH + GnRH-Antag Aromatase inhibitor increased intra-follicular androgen concentrations (not serum) Androgen priming was associated with an increased yield of high grade embryos
23 Summary The period prior to FSH induced growth is important because follicles must develop FSH sensitivity. Paracrine intrafollicular androgen drive may enhance FSH sensitivity by direct or indirect effects upon GCs. The question of whether exogenous LH, in isolation, can induce significant changes in follicular responses remains to be proven. There is good evidence that addressing this issue may prove clinically beneficial in the future. Addendum: It is unlikely that this approach will increase the yield of follicles / oocytes in poor responder patients.
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