Clinical Outcomes in WHO Type I Anovulatory Women Using r-hFSH+r-hLH in a 2:1 Ratio or hMG-HP
Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
The aim of the study is to compare the efficacy and safety of r-hFSH+r-hLH in a 2:1 ratio
with human Menopausal Gonadotropin Highly Purified (hMG-HP), in WHO type I anovulation, HH
women.
This open-label monocentric, randomized comparative trial, to receive the two different
standard clinical practice treatments:
- 1 vial of Pergoveris: (vial/powder 150 International unit (IU) r-hFSH+ 75IU r-hLH)
- 2 vials of Menopur: (vials/powder hMG 75IU).
Follicular development were monitored until the protocol hCG requirement is met and a single
injection of hCG was administered.
Main Outcome Measures were follicular development i.e. follicle ≥ 17 millimeters (mm),
pre-ovulatory E2 ≥ 400 picomole/Liter (pmol/L) and mid-luteal phase Progesterone (P4) ≥ 25
nanomole/Liter (nmol/L).