Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the study is to compare the safety and efficacy of r-hLH to r-hFSH in the late follicular phase of young women undergoing controlled ovarian stimulation for oocyte donation.
While the role of FSH is considered the fundamental driver of folliculogenesis, the role of LH in this process is more controversial. FSH is associated with stimulating growth and recruitment of follicles while LH is associated with the selection of dominant follicles destined for ovulation. We will use an open, prospective, cross-over study to compare the safety and efficacy of two different treatment protocols for controlled ovarian stimulation in egg donors.
20 participants will undergo two cycles of stimulation. The first one will be with r-hFSH though the cycle and the second with r-hFSH then r-hLH. The participants will have 1 month rest cycle between the treatment cycles. r-hFSH doses will be adjusted according to patient response. r-hLH dosing will begin when there are 2 follicles greater than or equal to 14mm in diameter. The does will be 300IU/day and continue until the day of r-hCG administration.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| r-hFSH (Gonal F) | Other | Patients will be treated with r-hFSH throughout the stimulation phase of their first cycle until r-hCG administration. |
|
| r-hFSH (Gonal F) and r-hLH (Luveris) | Other | Patients will be treated with r-hFSH only until they have 2 follicles greater than or equal to 14mm. Patients will then bring 300IU/day of r-hLH until r-hCG administration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| r-hFSH | Drug | r-hFSH dose to be determined by the patient's primary doctor and adjusted according to their response |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and efficacy of r-hFSH protocol | Evaluation of the safety and efficacy of r-hFSH for controlled ovarian stimulation in the same patients. | 6 months |
| Safety and efficacy of r-hFSH + r-hLH protocol | Evaluation of the safety and efficacy of r-hFSH for controlled ovarian stimulation in the same patients. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of oocytes retrieved | Evaluation of the number of oocytes obtained as a function of stimulation protocol. | 6 months |
| Quality of embryos obtained | Evaluation of pregnancy rates (clinical and ongoing), delivery rates, multiple pregnancy rates and the number of cancelled cycles. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard T Scott, MD | Reproductive Medicine Associates of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Medicine Assoicates of New Jersey | Morristown | New Jersey | 07960 | United States |
Not provided
| ID | Term |
|---|---|
| C571801 | follitropin alfa |
| D037101 | Luteinizing Hormone, beta Subunit |
| ID | Term |
|---|---|
| D007986 | Luteinizing Hormone |
| D006065 | Gonadotropins, Pituitary |
| D006062 | Gonadotropins |
| D036361 | Peptide Hormones |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| r-hFSH and r-hLH | Drug | Patients will begin r-hLH at 300IU/day when there are 2 follicles greater than or equal to 14mm. |
|
|
| 6 months |
| Incidences of ovarian hyperstimulation syndrome | Evaluation of the potential adverse effects associated with ovarian stimulation | 6 months |
| Quality of oocytes obtained | Evaluation of the quality of oocytes obtained as a function of stimulation protocol. | 6 months |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |