NCT01623570

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
Last Updated

June 20, 2012

Status Verified

June 1, 2012

Enrollment Period

1.2 years

First QC Date

June 17, 2012

Last Update Submit

June 17, 2012

Conditions

Hypogonadotropic Hypogonadism

Keywords

Luteinizing HormoneHypogonadotropic HypogonadismOvulation InductionChorionic Gonadotropin

Outcome Measures

Primary Outcomes (3)

  • E2 in pmol/L

    Evaluate the patients steroidogenesis

    Day after the protocol hCG requirement is met (at least one follicle of 17mm is monitored by ultrasound)

  • Number of Follicles > 17mm

    To evaluate the efficacy of the stimulation and maturity of follicles

    last US day before hCG administration

  • P4 in nmol/L

    Progesteron level to evaluate the endometrial receptivity

    Day after the protocol hCG requirement is met (at least one follicle of 17mm by US)

Secondary Outcomes (4)

  • Endometrial thickness

    Day 5 and Day 10 of stimulation treatment

  • Total number of Follicles

    Last US day before hCG administration

  • Clinical Pregnancy rate

    days 35-42 post hCG

  • Occurence of any adverse events (early or late ovarian hyperstimulation syndrome)

    Days 15-20 post hCG

Study Arms (2)

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

EXPERIMENTAL

This is a prospective randomized study using two in-label treatments for the patient disease: Pergoveris and Menopur. Pergoveris arms can be considered as experimental for the aim of the study, anyway it is standard routine practice for HH women.

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

Menopur: hMG-HP (150IU)

EXPERIMENTAL

This is a prospective randomized study using two in-label treatments for the patient disease: Pergoveris and Menopur. Menopur can be considered as experimental for the aim of the study, anyway it is standard routine practice for HH women

Drug: Menopur: HMG-HP (150 IU)

Interventions

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

Fixed formulation of two recombinant gonadotropins

Also known as: Pergoveris
Pergoveris: 150IU r-hFSH+ 75IU r-hLH
Menopur: HMG-HP (150 IU)DRUG

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

Also known as: Menopur
Menopur: hMG-HP (150IU)

Eligibility Criteria

Age25 Years - 36 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • WHO Type I HH Women
  • Serum LH \<1.2 IU/L
  • Serum FSH \<5 IU/L
  • Age 25-36 years
  • No ovarian tumor
  • No cyst
  • ≤ 13 small follicles (mean diameter ≤ 10mm)
  • BMI between 18 - 32 Kg/m2
  • no systemic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Riproduzione e Andrologia

Taranto, Italy, 74100, Italy

Location

Related Publications (1)

  • Carone D, Caropreso C, Vitti A, Chiappetta R. Efficacy of different gonadotropin combinations to support ovulation induction in WHO type I anovulation infertility: clinical evidences of human recombinant FSH/human recombinant LH in a 2:1 ratio and highly purified human menopausal gonadotropin stimulation protocols. J Endocrinol Invest. 2012 Dec;35(11):996-1002. doi: 10.3275/8657. Epub 2012 Oct 22.

    PMID: 23095369DERIVED

MeSH Terms

Conditions

Hypogonadism

Interventions

pergoverisMenotropins

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, PituitaryGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPituitary Hormones, AnteriorPituitary HormonesPeptidesAmino Acids, Peptides, and ProteinsBiological ProductsComplex Mixtures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 17, 2012

First Posted

June 20, 2012

Study Start

March 1, 2011

Primary Completion

May 1, 2012

Study Completion

June 1, 2012

Last Updated

June 20, 2012

Record last verified: 2012-06

Locations

IT(1)