Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440258
Status:
COMPLETED
Last Update Posted:
2007-02-27
First Post:
2007-02-23
Brief Title:
Cabergoline Reduces OHSS
Sponsor:
Instituto Valenciano de Infertilidad IVI VALENCIA
Organization:
Instituto Valenciano de Infertilidad IVI VALENCIA
Study Overview
Official Title:
Dopamine Agonist Cabergoline Reduces Hemoconcentration and Ascites in Hyperstimulated Women Undergoing Assisted Reproduction
Status:
COMPLETED
Status Verified Date:
2007-02
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 present study was designed to provide clinical confirmation of Cb2s value as a new approach in the prevention of increased vascular permeability and hemoconcentration both signs of OHSS in humans and in order to explore its mechanism of action To this end a prospective randomized placebo-controlled study was designed in which Cb2 was employed in women at risk of OHSS after gonadotropin administration for ART Simultaneously ovarian perfusion was assessed in these patients using MR pharmacokinetic modeling
Detailed Description:
Patients and Study design This study was performed in 82 oocyte donors between April 2004 and July 2006 The study protocol was approved by our institutions Ethical Committee and all participants signed a written consent form The protocol for COH has previously been described 23 Only patients at risk of developing OHSS were included The definition of risk was the development of 20-30 follicles 12 mm in diameter and retrieval of 20 oocytes Once the decision to administer hCG was taken patients were immediately allocated into two groups based on a computer randomization the study group initially consisted of 41 patients but 6 of these were discarded after randomization because 20 oocytes were retrieved despite the development of 20 follicles 12 mm Thus a remaining total of 35 patients received one 05 mg tablet of Cb2 daily for eight days The control group was also initially composed of 41 women However 7 of these did not meet the criteria of number of oocytes retrieved and 2 donors decided to withdraw themselves from the study This left a remaining total of 32 women all of whom completed the study and who received a placebo tablet daily for 8 days Women were monitored every 48 hours from the day of hCG day 0 until day 8
On day hCG4 in order to define ascites and provided that there was a certain degree of fluid in the pouch of Douglas after ovum pick-up we employed transvaginal ultrasound TVU to measure two major perpendicular diameters of fluid pockets in 15 donors who showed no risk of OHSS We observed 3528 cm2 of fluid in the pelvis in normal conditions Therefore the existence of ascites was confirmed when a pocket of peritoneal fluid 9 cm2 was observed when the patient was in lithotomy position with the gynecological table always at 45ยบ from the floor of the room which is the result of the mean 2 standard deviations SD of the value found in non-OHSS candidates TVU scans were performed by the same researcher CA who was blind to the treatment to which the patient was submitted A 65 MHz vaginal probe Voluson 730 Pro V General Electric Madrid Spain was employed for all TVU scans
To evaluate the biochemical risk of hemoconcentration we evaluated hemoglobin hematocrit and leukocyte count Moreover renal creatinine and liver transaminases aspartate aminotransferase AST alanine aminotransferase ALT functions and electrolytes Na K were analyzed to ascertain the severity of the syndrome
Since all women undergoing ART experience a certain degree of discomfort and enlarged ovaries known as mild OHSS we centered our attention on analyzing the incidence of moderate and severe OHSS which were identified according to our modified 24 classification of Golan et al 25 Moderate OHSS was confirmed when a patient presented ultrasonographic evidence of ascites while diagnosis of severe OHSS required clinical evidence of ascites andor hydrothorax and breathing difficulties or one of the following criteria a increased blood viscosity due to hemoconcentration hemoglobin 15 gdl hematocrit 45 or leukocyte count 20000mm3 b coagulation abnormality c diminished renal perfusion and function serum creatinine levels 12 mgdl dliver dysfunction defined when transaminases AST or ALT were 40 Uml 24 25
Additionally serum PRL levels were measured and adverse drug reactions recorded An end-of-study assessment was scheduled 7-10 days after the last dose of Cb2placebo
Moreover in the first 8 patients included in the study follicular fluid aspirates without obvious blood contamination were collected pooled and and mRNA extracted to quantify the amount of Dp-r2 in human ovaries employing two different molecular techniques
To further objectively analyze changes in vascular permeability and fluid shifts confirmatory studies were performed on six women in the study group and four controls employing magnetic resonance MR as described below Dynamic contrast-enhanced MR was performed at three different stages of the study at baseline before gonadotropin administration was initiated just before hCG injection and on day hCG5 after oocyte pick-up
On day hCG4 in order to define ascites and provided that there was a certain degree of fluid in the pouch of Douglas after ovum pick-up we employed transvaginal ultrasound TVU to measure two major perpendicular diameters of fluid pockets in 15 donors who showed no risk of OHSS We observed 3528 cm2 of fluid in the pelvis in normal conditions Therefore the existence of ascites was confirmed when a pocket of peritoneal fluid 9 cm2 was observed when the patient was in lithotomy position with the gynecological table always at 45ยบ from the floor of the room which is the result of the mean 2 standard deviations SD of the value found in non-OHSS candidates TVU scans were performed by the same researcher CA who was blind to the treatment to which the patient was submitted A 65 MHz vaginal probe Voluson 730 Pro V General Electric Madrid Spain was employed for all TVU scans
To evaluate the biochemical risk of hemoconcentration we evaluated hemoglobin hematocrit and leukocyte count Moreover renal creatinine and liver transaminases aspartate aminotransferase AST alanine aminotransferase ALT functions and electrolytes Na K were analyzed to ascertain the severity of the syndrome
Since all women undergoing ART experience a certain degree of discomfort and enlarged ovaries known as mild OHSS we centered our attention on analyzing the incidence of moderate and severe OHSS which were identified according to our modified 24 classification of Golan et al 25 Moderate OHSS was confirmed when a patient presented ultrasonographic evidence of ascites while diagnosis of severe OHSS required clinical evidence of ascites andor hydrothorax and breathing difficulties or one of the following criteria a increased blood viscosity due to hemoconcentration hemoglobin 15 gdl hematocrit 45 or leukocyte count 20000mm3 b coagulation abnormality c diminished renal perfusion and function serum creatinine levels 12 mgdl dliver dysfunction defined when transaminases AST or ALT were 40 Uml 24 25
Additionally serum PRL levels were measured and adverse drug reactions recorded An end-of-study assessment was scheduled 7-10 days after the last dose of Cb2placebo
Moreover in the first 8 patients included in the study follicular fluid aspirates without obvious blood contamination were collected pooled and and mRNA extracted to quantify the amount of Dp-r2 in human ovaries employing two different molecular techniques
To further objectively analyze changes in vascular permeability and fluid shifts confirmatory studies were performed on six women in the study group and four controls employing magnetic resonance MR as described below Dynamic contrast-enhanced MR was performed at three different stages of the study at baseline before gonadotropin administration was initiated just before hCG injection and on day hCG5 after oocyte pick-up
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