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Comparison of efficacy and tolerability of freeze-dried and liquid formulations of urinary human chorionic gonadotropin for triggering ovulation

Tejshree Singh, MBBS, CPSDGO, MD, DNB*, Abha Majumdar, MBBS, MS, FICS**

*Consultant Infertility Unit, Department of Obstetrics and Gynaecology, Kolmet Hospital & Research Centre, New Delhi, India

**Senior Consultant and Head of the Unit of IVF and Human Reproduction, Department of Obstetrics and Gynaecology

Objective

Subjects and Methods Results To compare the efficacy and tolerability of freeze-dried and liquid formulations of urinary human chorionic gonadotropin (hCG) for inducing final oocyte maturation and triggering ovulation.

Subjects and Methods

In a randomized, single-centre study, infertile women (n=100) received single injections of urinary hCG (5000 IU) from reconstituted freeze-dried (1.0 mL of 5000 IU /mL) and liquid (0.5 mL of 5000 IU /0.5 mL) formulations in random order, when their ultrasounds showed one or more dominant follicles of size 18mm or above. Blood samples were taken after 36h for determination of hCG concentration by immunoassay using direct chemilluminometric technology. Follicular rupture was assessed by means of another ultrasound undertaken 48h following the injection of hCG and serum progesterone levels undertaken 8 days later

The mean serum hCG levels achieved 36 hours post hCG injection were 74.05 mIU/ml for the freeze-dried formulation and 69.65 mIU/ml for the liquid formulation. The mean difference between these levels was 4.400 (95%confidence interval -19.002 to 10.202) which is statistically not significant (p-value 0.545). These levels were equally effective for triggering ovulation. The mean serum progesterone levels achieved day 8 post hCG, were 8.452 ng/ml for the freeze-dried formulation and 8.228 ng/ml for the liquid formulation. Both formulations were tolerated well; the liquid formulation of hCG was associated with fewer adverse effects.

Discussion

The levels of hCG required to trigger follicular rupture are anywhere between 20 to 45 mIU/ml. As ovulation will happen about 36-48 hours after the injection of hCG, procedures can be scheduled to take advantage of this time sequence.

Review of literature

The liquid formulation of recombinant hCG was shown to be bioequivalent to the freeze-dried formulation, with the same efficacy and no clinically significant differences in tolerability.

Conclusion

Our study shows that the liquid formulation of urinary hCG provides the same efficacy as the freeze-dried formulation when used to trigger final follicular rupture, is convenient to use and has better tolerability.



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