Female Infertility Clinical Trial
Official title:
A Phase I, Monocenter, Randomized, Placebo and Comparator Controlled, Single Blind, Rising Dose, Clinical Study to Determine Single Dose Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Four Doses of FSH-GEX™ According to Adaptive Design (25, 75, 150 and 300 IU) Administered Subcutaneously in Healthy Pituitary-suppressed Female Volunteers
The aim of the current study was the pharmacokinetic and pharmacodynamic characterization of a single dose administration of four doses of FSH-GEX™ in healthy pituitary-suppressed female volunteers, in comparison with two marketed comparator products.
Healthy pituitary-suppressed female subjects received FSH-GEX™ (25, 75, 150 and 300 IU) in three of four possible ascending doses or one dose of two comparators (Bravelle® and Gonal-f®) and placebo in random order. The study consisted of three separate treatment periods. During each treatment period the subject received one single dose via a subcutaneous injection in the lower abdominal wall. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06239051 -
Greening the Humanitas Fertility Center: How to Build a More Sustainable Medical Daily Routine
|
||
| Recruiting |
NCT05179993 -
Detection of Microplastics in Human Granulosa Cells and in the Follicular Fluid of Women Undergoing ICSI Treatment
|
||
| Recruiting |
NCT03767569 -
Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients
|
Phase 3 | |
| Completed |
NCT03737253 -
Hormone Evaluation in Artificial Reproductive Technology
|
Phase 4 | |
| Not yet recruiting |
NCT02237755 -
Clomiphene Citrate in Combination With Gonadotropins for Ovarian Stimulation in Women With Poor Ovarian Response.
|
Phase 2/Phase 3 | |
| Not yet recruiting |
NCT02237781 -
Levels of Anti-Mullerian Hormone (AMH) During Ovarian Stimulation With Gonadotropins
|
Phase 2/Phase 3 | |
| Completed |
NCT01477073 -
Multiple Dose FSH-GEX(TM) in Healthy Volunteers
|
Phase 1 | |
| Recruiting |
NCT00119925 -
'SPRING'-Study: "Subfertility Guidelines: Patient Related Implementation in the Netherlands Among Gynaecologists"
|
N/A | |
| Recruiting |
NCT06098495 -
Looking for a Blood Epigenetic Signature to Predict Female Infertility
|
||
| Completed |
NCT03998553 -
Study for Obtaining Mature Oocytes by in Vitro Maturation in Oocyte-donor Women
|
N/A | |
| Completed |
NCT05189145 -
Hormonal Monitoring and Progesterone Adjustment in Frozen Embryo Transfer Cycles
|
N/A | |
| Recruiting |
NCT05050747 -
Study to Assess the Effect of Intrauterine Adminstration of HCG Versus Endometrial Injury by Pipelle
|
||
| Completed |
NCT01620346 -
Intracytoplasmic Morphologically Selected Sperm Injection and Advanced Maternal Age
|
N/A | |
| Completed |
NCT00315029 -
Patient-Centered Implementation Trial for Single Embryo Transfer
|
N/A | |
| Recruiting |
NCT03080584 -
Effect of 12 Weeks of Acupuncture on AMH and COH in Low Responder Patients
|
N/A | |
| Not yet recruiting |
NCT05106712 -
Vitamin D Supplementation and Improvement of PCOS Therapy and IVF Outcomes in Infertile Saudi Women
|
N/A | |
| Recruiting |
NCT06041204 -
Best Treatment for Women With Both (Polycystic Ovary Syndrome) PCOS and Subclinical Hypothyroidism
|
N/A | |
| Completed |
NCT01604044 -
Highly Purified Menotropin (HP-hMG) Versus Recombinant FSH (rFSH) Plus Recombinant LH (rLH) in Intrauterine Insemination Cycles in Women ≥35 Years: a Prospective Randomized Trial.
|
Phase 1 | |
| Completed |
NCT02328924 -
There is a Value of Luteinizing Hormone Predictive of in Vitro Fertilization Treatment Outcome in Antagonist Protocols?
|
Phase 4 | |
| Completed |
NCT04019899 -
Myo-inositol and Vitamin D3 During IVF
|
N/A |