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Clinical Outcomes in WHO Type I Anovulatory Women Using r-hFSH+r-hLH in a 2:1 Ratio or hMG-HP

NCT01623570 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-06-20

No results posted yet for this study

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).

Conditions

  • Hypogonadotropic Hypogonadism

Interventions

DRUG

Pergoveris: 150IU r-hFSH + 75IU r-hLH

Fixed formulation of two recombinant gonadotropins

DRUG

Menopur: HMG-HP (150 IU)

Human Menopausal Gonadotropin is an urinary estract from menopausal women containing 150IU of FSH and 150 IU of LH-like activity (HCG)

Sponsors & Collaborators

  • Centro Riproduzione e Andrologia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
36 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-05-31
Completion
2012-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01623570 on ClinicalTrials.gov