scholarly journals First pre-filled pen device with highly purified human menopausal gonadotropin (HP-hMG, Menopur) in liquid is shown to be bioequivalent to powder for reconstitution

Author(s):  
Daniël M. Jonker ◽  
Manuela Koch ◽  
Per Larsson ◽  
Arjun Ravi ◽  
Birgitte Buur Rasmussen ◽  
...  
2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Klaus F. Bühler ◽  
Robert Fischer ◽  
Patrice Verpillat ◽  
Arthur Allignol ◽  
Sandra Guedes ◽  
...  

Abstract Background This study compared the effectiveness of recombinant human follicle-stimulating hormone alfa (r-hFSH-alfa; GONAL-f®) with urinary highly purified human menopausal gonadotropin (hMG HP; Menogon HP®), during assisted reproductive technology (ART) treatments in Germany. Methods Data were collected from 71 German fertility centres between 01 January 2007 and 31 December 2012, for women undergoing a first stimulation cycle of ART treatment with r-hFSH-alfa or hMG HP. Primary outcomes were live birth, ongoing pregnancy and clinical pregnancy, based on cumulative data (fresh and frozen-thawed embryo transfers), analysed per patient (pP), per complete cycle (pCC) and per first complete cycle (pFC). Secondary outcomes were pregnancy loss (analysed per clinical pregnancy), cancelled cycles (analysed pCC), total drug usage per oocyte retrieved and time-to-live birth (TTLB; per calendar week and per cycle). Results Twenty-eight thousand six hundred forty-one women initiated a first treatment cycle (r-hFSH-alfa: 17,725 [61.9%]; hMG HP: 10,916 [38.1%]). After adjustment for confounding variables, treatment with r-hFSH-alfa versus hMG HP was associated with a significantly higher probability of live birth (hazard ratio [HR]-pP [95% confidence interval (CI)]: 1.10 [1.04, 1.16]; HR-pCC [95% CI]: 1.13 [1.08, 1.19]; relative risk [RR]-pFC [95% CI]: 1.09 [1.05, 1.15], ongoing pregnancy (HR-pP [95% CI]: 1.10 [1.04, 1.16]; HR-pCC [95% CI]: 1.13 [1.08, 1.19]; RR-pFC [95% CI]: 1.10 [1.05, 1.15]) and clinical pregnancy (HR-pP [95% CI]: 1.10 [1.05, 1.14]; HR-pCC [95% CI]: 1.14 [1.10, 1.19]; RR-pFC [95% CI]: 1.10 [1.06, 1.14]). Women treated with r-hFSH-alfa versus hMG HP had no statistically significant difference in pregnancy loss (HR [95% CI]: 1.07 [0.98, 1.17], were less likely to have a cycle cancellation (HR [95% CI]: 0.91 [0.84, 0.99]) and had no statistically significant difference in TTLB when measured in weeks (HR [95% CI]: 1.02 [0.97, 1.07]; p = 0.548); however, r-hFSH-alfa was associated with a significantly shorter TTLB when measured in cycles versus hMG HP (HR [95% CI]: 1.07 [1.02, 1.13]; p = 0.003). There was an average of 47% less drug used per oocyte retrieved with r-hFSH-alfa versus hMG HP. Conclusions This large (> 28,000 women), real-world study demonstrated significantly higher rates of cumulative live birth, cumulative ongoing pregnancy and cumulative clinical pregnancy with r-hFSH-alfa versus hMG HP.


Author(s):  
Arie A Polim ◽  
Ivan R Sini ◽  
Indra NC Anwar ◽  
Aryando Pradana ◽  
Kurniawati Kurniawati ◽  
...  

Objective: To investigate the role of CC-highly purified Human Menopausal Gonadotropin (hpHMG) and Growth Hormone (GH) in mini-stimulation protocol to improve outcome in poor ovarian responders (POR). Method: All patients were given clomiphene citrate 150 mg from day 3 to day 7 of menstrual cycle followed by 150 IU hpHMG daily from day 8 until ovulation trigger. Two groups were observed where one group received GH and the other arm did not. In the GH group, 8 IU of GH were given from day 1 of stimulation until stimulation was stopped. GnRH antagonist was used to suppress ovulation. Result: Among 51 eligible women, 29 patients with GH and 22 patients without GH, no difference was observed in the number of oocytes retrieved (2.21 versus 2.64) and the number of embryos transferred (1.24 versus 1.68) in the GH group versus the group without GH, respectively. Total clinical pregnancy rate was 17.6%. No significant difference in pregnancy and ongoing pregnancy rate in both groups (17.2% versus 18.2%) and (13.8% versus 13.6%), respectively. In patients older than 40 years old, GH showed a 4-fold likelihood in producing top quality embryos (44.8% vs 13.6%, OR=3.6, p=0.05). Conclusion: CC-HMG regimen in mini-stimulation protocol is an effective option in poor responders. Additional GH in ministimulation program provided a higher number of top quality embryos in women older than 40 years old, although there were no difference in clinical or ongoing pregnancy rate. Keywords: CC-HMG, growth hormone, IVF, mini-stimulation protocol, poor ovarian responders


2020 ◽  
Vol 40 (1) ◽  
Author(s):  
Dragos Albu ◽  
Alice Albu

Abstract We performed a retrospective study aiming to study the relationship between the ratio of the exogenous luteinizing hormone to follicle stimulating hormone (LH/FSH) administrated for controlled ovarian stimulation (COS) and the number and competence of the oocytes retrieved for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). Eight hundred sixty-eight consecutive infertile patients (mean age 34.54 ± 4.01 years, mean anti-Müllerian hormone (AMH) 2.94 ± 2.07 ng/ml) treated with long agonist protocol and a mixed gonadotropin protocol (human menopausal gonadotropin in association with recombinant FSH (recFSH)) who performed IVF/ICSI between January 2013 and February 2016, were included. Patients with severe male factor were excluded. LH/FSH was calculated based on total doses of the two gonadotropins. We found, after adjustment for confounders, a positive relationship between LH/FSH and the retrieved oocytes’ (β = 0.229, P<0.0001) and zygotes’ number (β = 0.144, P<0.0001) in the entire study group and in subgroups according to age (<35 and ≥35 years) and ovarian reserve (AMH < 1.1 and ≥ 1.1 ng/ml). The fertilization rate was positively associated with LH/FSH in patients with LH/FSH in the lowest three quartiles (below 0.77) (β = 0.096, P=0.034). However, patients in the fourth quartile of LH/FSH had a lower fertilization rate as compared with patients in quartiles 1–3 which, after adjustment for covariates, was only marginally negatively related with LH/FSH (β = −0.108, P=0.05). In conclusion, our results suggest that the adequate LH/FSH administrated during COS can improve the oocytes’ and zygotes’ number in IVF/ICSI cycles, but also the fertilization rate when a certain proportion of LH/FSH is not exceeded.


1983 ◽  
Vol 38 (9) ◽  
pp. 578-579
Author(s):  
ZION BEN-RAFAEL ◽  
JEHOSHUA DOR ◽  
SCHLOMO MASHIACH ◽  
JOSEF BLANKSTEIN ◽  
BRUNO LUNENFELD ◽  
...  

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