Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441324
Status:
COMPLETED
Last Update Posted:
2007-02-28
First Post:
2007-02-27
Brief Title:
Efficacy and Safety of R-hLH Luveris Priming Prior to R-HFSH Treatment in Infertile Women Undergoing IVF-ET
Sponsor:
NHS Greater Glasgow and Clyde
Organization:
NHS Greater Clyde and Glasgow
Study Overview
Official Title:
Efficacy and Safety of R-hLH Luveris Priming Prior to R-HFSH Treatment in Infertile Women Undergoing IVF-ET
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:
In programmes of IVF normal women undergo controlled ovarian stimulation using exogenous FSH injections to obtain multiple eggs The process results in eggs of mixed quality with a broad range of developmental and implantation potential
The aim of the study was to determine whether treatment with recombinant human LH prior to the FSH injections can improve outcome for women undergoing IVF High grade embryos implant with a higher frequency and baby delivery rate than poor quality embryos The mature oocyte is the most important determinant of embryo quality Early follicles containing immature eggs have LH receptors in the theca cells that surround the follicle and LH stimulates these cells to produce factors essential for normal follicular development
The intent of the study was to use recLH treatment prior to recFSH to treat a cohort of follicles so that they can all mature together thus increasing the proportion of high grade oocytes and their subsequent embryos
The aim of the study was to determine whether treatment with recombinant human LH prior to the FSH injections can improve outcome for women undergoing IVF High grade embryos implant with a higher frequency and baby delivery rate than poor quality embryos The mature oocyte is the most important determinant of embryo quality Early follicles containing immature eggs have LH receptors in the theca cells that surround the follicle and LH stimulates these cells to produce factors essential for normal follicular development
The intent of the study was to use recLH treatment prior to recFSH to treat a cohort of follicles so that they can all mature together thus increasing the proportion of high grade oocytes and their subsequent embryos
Detailed Description:
Normal women undergoing IVF Total n 146 GRI n 43 were recruited in 4 centres in 3 countries and all were started on treatment with a depo GnRH-agonist to suppress endogenous gonadotropin secretion Block randomisation lead to a distribution 71 untreated cases and 75 cases treated with rec-hLH LuverisSerono 300IUd for 7 days On the following days recombinant follicle stimulating hormone rec-hFSH stimulation of the ovaries was initiated using Gonal-f 150IUd for approximately 12 days
HCG 3500IU was given when 2 mature follicles were seen by ovarian ultrasound and oocytes eggs were fertilized in vitro after collection between 36 and 38h after the injection Embryos were scored for quality and a maximum of 2 embryos were transferred 2 or 3 days later
Results During Luveris treatment the LH concentration was increased by approximately 3 IUL but there was no change in the hormone profiles of androgens or estrogens in blood samples measured in a central laboratory Both groups of patients showed an increase in the circulating anti-mullerian hormone although there was no difference between the groups
The Luveris treated group showed a significant p0007 increase in the number of small antral follicles but to a degree that was not different from the control group
During rec-hFSH stimulation there was no difference in the duration of FSH injections required or the total dose or the total number of follicles seen or the hormone profiles observed
The Luveris pre-treated group showed a slight not significant increase in oocyte yield In this group there was a significant increase in the normally fertilized embryo yield no treatment mean 51 Luveris treatment mean 70 p 0038
Discussion The observations of negligible effects of LH upon the hormone profiles may be explained by the fact that the hormone concetrations were at the lower limit of sensitivity of the assay methods and they do not preclude an effect within the follicles We did observe effects upon follicular development in the ultrasound profiles Effects upon hormone profiles may require both hormones LH and FSH to be present at the same time instead of in sequence
The small effect of the pre-treatment upon normal embryo yield may be an important observation
Conclusion These results demonstrate that treating follicles with LH prior to FSH may lead to the development of more viable follicles than with FSH treatment alone This should lead to improved regimes of ovarian stimulation and improve the outcome potential for women undergoing IVF
Future Research Exploration of this phenomenon will be required in order to maximise any potential benefit from the process There are numerous sub-groups of patients who may possibly benefit including poor responding patients but further data are required
HCG 3500IU was given when 2 mature follicles were seen by ovarian ultrasound and oocytes eggs were fertilized in vitro after collection between 36 and 38h after the injection Embryos were scored for quality and a maximum of 2 embryos were transferred 2 or 3 days later
Results During Luveris treatment the LH concentration was increased by approximately 3 IUL but there was no change in the hormone profiles of androgens or estrogens in blood samples measured in a central laboratory Both groups of patients showed an increase in the circulating anti-mullerian hormone although there was no difference between the groups
The Luveris treated group showed a significant p0007 increase in the number of small antral follicles but to a degree that was not different from the control group
During rec-hFSH stimulation there was no difference in the duration of FSH injections required or the total dose or the total number of follicles seen or the hormone profiles observed
The Luveris pre-treated group showed a slight not significant increase in oocyte yield In this group there was a significant increase in the normally fertilized embryo yield no treatment mean 51 Luveris treatment mean 70 p 0038
Discussion The observations of negligible effects of LH upon the hormone profiles may be explained by the fact that the hormone concetrations were at the lower limit of sensitivity of the assay methods and they do not preclude an effect within the follicles We did observe effects upon follicular development in the ultrasound profiles Effects upon hormone profiles may require both hormones LH and FSH to be present at the same time instead of in sequence
The small effect of the pre-treatment upon normal embryo yield may be an important observation
Conclusion These results demonstrate that treating follicles with LH prior to FSH may lead to the development of more viable follicles than with FSH treatment alone This should lead to improved regimes of ovarian stimulation and improve the outcome potential for women undergoing IVF
Future Research Exploration of this phenomenon will be required in order to maximise any potential benefit from the process There are numerous sub-groups of patients who may possibly benefit including poor responding patients but further data are required
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