Ignite Creation Date:
2024-05-06 @ 12:40 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01623570
Status:
COMPLETED
Last Update Posted:
2012-06-20
First Post:
2012-06-17
Brief Title:
Clinical Outcomes in WHO Type I Anovulatory Women Using r-hFSHr-hLH in a 21 Ratio or hMG-HP
Sponsor:
Centro Riproduzione e Andrologia
Organization:
Centro Riproduzione e Andrologia
Study Overview
Official Title:
Prospective Randomized Open Label Study to Compare the Efficacy and Safety of Ovarian Stimulation With Pergoveris and Menopur in Women With Severe Luteinizing Hormone LH and Follicular Stimulating Hormone FSH Deficiency
Status:
COMPLETED
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to compare the efficacy and safety of r-hFSHr-hLH in a 21 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 vialpowder 150 International unit IU r-hFSH 75IU r-hLH
2 vials of Menopur vialspowder 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 ie follicle 17 millimeters mm pre-ovulatory E2 400 picomoleLiter pmolL and mid-luteal phase Progesterone P4 25 nanomoleLiter nmolL
This open-label monocentric randomized comparative trial to receive the two different standard clinical practice treatments
1 vial of Pergoveris vialpowder 150 International unit IU r-hFSH 75IU r-hLH
2 vials of Menopur vialspowder 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 ie follicle 17 millimeters mm pre-ovulatory E2 400 picomoleLiter pmolL and mid-luteal phase Progesterone P4 25 nanomoleLiter nmolL
Detailed Description:
World Health Organization WHO type I hypogonadotropic anovulation hypogonadotropic hypogonadism HH is a rare alteration of the reproductive system with absent or decreased function of the gonads caused by congenital including genetic or acquired reduced hypothalamic or pituitary activity This results in abnormally low serum levels of Follicular Stimulation Hormone FSH and Luteinizing Hormone LH and negligible oestrogen E2 activity
The most convenient treatment is daily injections of exogenous gonadotropins that has been proven to be effective
Patients lacking an effective hypothalamic-pituitary activity WHO type I anovulation do not produce sufficient threshold levels of endogenous LH which is required to obtain optimal follicular development and steroidogenesis when treated with FSH alone Therefore a combination therapy with adequate doses of both FSH and LH in an optimal ratio is required in order to restore fertility
The LH activity could be produced by LH itself or by human Chorionic Gonadotropin hCG and the two gonadotropins are available to be used in the WHO type I patients in two different formulations both in indication for this type of patients It would be worth of interest to assess if these two different formulations could elicit the same clinical outcomes in standard clinical practice or not
The aim of the study is to compare the efficacy and safety of recombinant human FSH and recombinant human LH r-hFSHr-hLH in a 21 ratio with human Menopausal Gonadotropin Highly Purified hMG-HP containing LH-like activity in women with severe LH and FSH deficiency WHO type I anovulation HH
All patients were diagnosed with HH according to a negative progesterone P4 challenge test serum LH12 IUL and FSH 5 IUL a transvaginal ultrasound showing a uterus with a midline echo no ovarian tumor or cyst and 13 small follicles mean diameter 10millimeters mm on the largest section through each ovary a Body Mass Index BMI between 18 and 32 Kilograms for square metersKgm2 and no systemic diseases
In this open-label monocentric randomized comparative trial patients was randomized in two arms in 11 ratio to receive the two different standard clinical practice treatments
1 vial of Pergoveris vialpowder 150 International Units IU r-hFSH 75IU r-hLHstimulation day 1 until required hCG level is met The dose can be adjusted at stimulation Day 6 according to subject ovarian response and standard clinical practice
2 vials of Menopur vialpowder hMG containing 75IU FSH 75IU LH-like activity stimulation day 1 until required hCG level is met The dose can be adjusted at stimulation Day 6 according to subject ovarian response and standard clinical practice Follicular development were monitored according clinical practice by ultrasound US andor estradiol E2 levels until the protocol hCG requirement is met ie at least one follicle greater than or equal to 17 mm After this a single injection of hCG was administered in order to induce final oocyte maturation
Main Outcome Measures were ovulation induction as measured by follicular development ie follicle 17 mm pre-ovulatory E2 400 picomoleLiter pmolL and mid-luteal phase Progesterone 25 nanomoleLiter nmolL Secondary efficacy endpoints included estradiol levelsfollicle at mid-cycle number of follicles at mid-cycle and pregnancy rate PR
Drug safety was assessed by monitoring adverse events and the incidence of local reactions after drug injection at local site Ovarian hyperstimulation syndrome OHSS was assessed and recorded according to Golan classification According to this protocol patients were initially treated for one cycle If consenting patients who did not become pregnant during the first cycle were treated for a further optional one or two series of cycles with the same criteria of randomization ie maintaining the same treatment as the previous cycle
The most convenient treatment is daily injections of exogenous gonadotropins that has been proven to be effective
Patients lacking an effective hypothalamic-pituitary activity WHO type I anovulation do not produce sufficient threshold levels of endogenous LH which is required to obtain optimal follicular development and steroidogenesis when treated with FSH alone Therefore a combination therapy with adequate doses of both FSH and LH in an optimal ratio is required in order to restore fertility
The LH activity could be produced by LH itself or by human Chorionic Gonadotropin hCG and the two gonadotropins are available to be used in the WHO type I patients in two different formulations both in indication for this type of patients It would be worth of interest to assess if these two different formulations could elicit the same clinical outcomes in standard clinical practice or not
The aim of the study is to compare the efficacy and safety of recombinant human FSH and recombinant human LH r-hFSHr-hLH in a 21 ratio with human Menopausal Gonadotropin Highly Purified hMG-HP containing LH-like activity in women with severe LH and FSH deficiency WHO type I anovulation HH
All patients were diagnosed with HH according to a negative progesterone P4 challenge test serum LH12 IUL and FSH 5 IUL a transvaginal ultrasound showing a uterus with a midline echo no ovarian tumor or cyst and 13 small follicles mean diameter 10millimeters mm on the largest section through each ovary a Body Mass Index BMI between 18 and 32 Kilograms for square metersKgm2 and no systemic diseases
In this open-label monocentric randomized comparative trial patients was randomized in two arms in 11 ratio to receive the two different standard clinical practice treatments
1 vial of Pergoveris vialpowder 150 International Units IU r-hFSH 75IU r-hLHstimulation day 1 until required hCG level is met The dose can be adjusted at stimulation Day 6 according to subject ovarian response and standard clinical practice
2 vials of Menopur vialpowder hMG containing 75IU FSH 75IU LH-like activity stimulation day 1 until required hCG level is met The dose can be adjusted at stimulation Day 6 according to subject ovarian response and standard clinical practice Follicular development were monitored according clinical practice by ultrasound US andor estradiol E2 levels until the protocol hCG requirement is met ie at least one follicle greater than or equal to 17 mm After this a single injection of hCG was administered in order to induce final oocyte maturation
Main Outcome Measures were ovulation induction as measured by follicular development ie follicle 17 mm pre-ovulatory E2 400 picomoleLiter pmolL and mid-luteal phase Progesterone 25 nanomoleLiter nmolL Secondary efficacy endpoints included estradiol levelsfollicle at mid-cycle number of follicles at mid-cycle and pregnancy rate PR
Drug safety was assessed by monitoring adverse events and the incidence of local reactions after drug injection at local site Ovarian hyperstimulation syndrome OHSS was assessed and recorded according to Golan classification According to this protocol patients were initially treated for one cycle If consenting patients who did not become pregnant during the first cycle were treated for a further optional one or two series of cycles with the same criteria of randomization ie maintaining the same treatment as the previous cycle
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None