Ignite Creation Date:
2025-12-24 @ 4:20 PM
Ignite Modification Date:
2025-12-26 @ 8:53 AM
Study NCT ID:
NCT01152866
Status:
COMPLETED
Last Update Posted:
2013-08-06
First Post:
2010-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open Label, Canadian Phase IIIb Study With Ovidrel in Ovulation Induction (OI) and Assisted Reproductive Technique (ART)
Sponsor:
EMD Serono
Organization:
Study Overview
Official Title:
An Observational Study Using Subcutaneous Ovidrel (Choriogonadotrophin Alfa) for Induction of Final Follicular Maturation and Early Luteinisation in Women Undergoing Ovarian Stimulation With Recombinant-human Follicle Stimulating Hormone (r-hFSH [Gonal-F®]).
Status:
COMPLETED
Status Verified Date:
2013-08
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:
With the development of the recombinant gonadotrophins, the use of human source proteins for the production of hormones has become unnecessary. These proteins, which are found in urinary preparations, have been thought to cause the local, post-injection adverse events (AEs) in some subjects.
There has been a demand by physicians for an alternative to urinary products for treatment. Due to allergies to urinary products, or other personal reasons, subjects were not able or willing to be treated with proteins of human origin. This study allowed subjects to be treated with the recombinant human chorionic gonadotropin (r hCG) (free of urinary proteins), which otherwise would not be possible. The study sponsor used this opportunity to collect additional safety data on the new recombinant product, (Ovidrel, r-hCG).
There has been a demand by physicians for an alternative to urinary products for treatment. Due to allergies to urinary products, or other personal reasons, subjects were not able or willing to be treated with proteins of human origin. This study allowed subjects to be treated with the recombinant human chorionic gonadotropin (r hCG) (free of urinary proteins), which otherwise would not be possible. The study sponsor used this opportunity to collect additional safety data on the new recombinant product, (Ovidrel, r-hCG).
Detailed Description:
Approximately one in ten couples of reproductive age experiences infertility. Infertility may be caused by problems in men, in women or in both. A number of techniques can be used depending on the duration and type of infertility problems. The treatment of ovulation induction (OI) uses the help of exogenous gonadotrophins such as follicle stimulating hormone (FSH), luteinizing hormone (LH) and hCG in order to stimulate follicles and release oocytes for fertilization in the fallopian tubes.
Assisted reproductive technologies (ARTs), including in-vitro fertilization (IVF) and intra- cytoplasmic sperm injection (ICSI), increases the chances of success to obtain more than one embryo. In order to obtain more than one embryo, it is necessary to stimulate the growth and maturation of several follicles. Such a multiple follicular development is obtained by daily administration of a follicle stimulating hormone (r-hFSH, Gonal-F). When these follicles have reached a large enough size, the role of hCG is to achieve final oocyte maturation and initiation of follicular luteinization.
Serono International S.A. has developed a pharmaceutical preparation of human chorionic gonadotrophin (hCG) for clinical use through the application of recombinant DNA technology. The resulting product is choriogonadotrophin alpha, a pure recombinant human chorionic gonadotrophin (r-hCG). The corresponding drug product is marketed under the tradename Ovidrel. Ovidrel (choriogonadotrophin alpha for injection) has been approved in the United States, in the European Union and Australia.
OBJECTIVES The objective of this study was to collect safety information in order to confirm the already known profile of r- hCG (Ovidrel).
Assisted reproductive technologies (ARTs), including in-vitro fertilization (IVF) and intra- cytoplasmic sperm injection (ICSI), increases the chances of success to obtain more than one embryo. In order to obtain more than one embryo, it is necessary to stimulate the growth and maturation of several follicles. Such a multiple follicular development is obtained by daily administration of a follicle stimulating hormone (r-hFSH, Gonal-F). When these follicles have reached a large enough size, the role of hCG is to achieve final oocyte maturation and initiation of follicular luteinization.
Serono International S.A. has developed a pharmaceutical preparation of human chorionic gonadotrophin (hCG) for clinical use through the application of recombinant DNA technology. The resulting product is choriogonadotrophin alpha, a pure recombinant human chorionic gonadotrophin (r-hCG). The corresponding drug product is marketed under the tradename Ovidrel. Ovidrel (choriogonadotrophin alpha for injection) has been approved in the United States, in the European Union and Australia.
OBJECTIVES The objective of this study was to collect safety information in order to confirm the already known profile of r- hCG (Ovidrel).
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: