Infertility Clinical Trial
Official title:
Non-interventional Observational Study to Evaluate the Baseline FSH, Ovarian Volume and AFC (Antral Follicle Count) as Prognostic Factors of the Outcome of the In-vitro Fertilization/Intracytosolic Sperm Injection (IVF/ICSI) in Infertile Patients Who Receive r-FSH (GONAL-f®) for Controlled Ovarian Hyperstimulation
Verified date | February 2014 |
Source | Merck KGaA |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: National Organization of Medicines |
Study type | Observational |
This is a phase IV non-interventional, multicentric observational study to evaluate the baseline follicle stimulating hormone (FSH) levels, ovarian volume, antral follicle count (AFC) and age as prognostic factors of the outcome of the in-vitro fertilisation/intracytosolic sperm injection (IVF/ICSI) in infertile subjects receiving Gonal-f for controlled ovarian hyperstimulation (COH).
Status | Completed |
Enrollment | 356 |
Est. completion date | January 2011 |
Est. primary completion date | January 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 43 Years |
Eligibility |
Inclusion Criteria: - Pre-menopausal female subjects aged between 20-43 years - Subjects requiring treatment with recombinant FSH for COH for IVF and/or ICSI - Subjects who are able to communicate well with the investigator and can comply with the requirements of the entire study - Subjects who have given written informed consent, prior to treatment, with the understanding that consent may be withdrawn by the subject at any time without prejudice Exclusion Criteria: - Female subjects not pregnant or lactating - Subjects with known allergic reaction against one of the ingredients - Subjects with enlarged ovaries or cysts unrelated to polycystic ovarian disease. - Subjects with gynaecological bleeding of unknown origin - Subjects with ovarian, uterine, or mammary cancer - Subjects with hyperprolactinaemia - Subjects with tumors of the hypothalamus or the pituitary gland |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Greece | Centre of Assisted Reproduction "Embryoland" | Athens |
Lead Sponsor | Collaborator |
---|---|
Merck KGaA |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Live birth rate | Up to 28 days after birth | No | |
Secondary | Pregnancy rate (ongoing, clinical, biochemical) | Biochemical: up to 2 weeks post embryo-transfer / clinical: up to 12 weeks post embryo-transfer / ongoing: up to 40 weeks post embryo-transfer | up to 40 weeks post embryo-transfer | No |
Secondary | Fertilization rate | 24 hours post oocyte retrieval | No | |
Secondary | Implantation rate | 2 weeks post embryo-transfer | No | |
Secondary | Detailed record of adverse events | Up to 1 year after subject enrollment | Yes | |
Secondary | Hormone (E2) levels on hCG day | Up to 12 hours prior to hCG administration | No | |
Secondary | Duration of treatment | Up to 12 hours post last FSH injection | No | |
Secondary | Total amount of FSH administered | Up to 1 hour post last FSH injection | No | |
Secondary | Number of oocytes | Up to 1 hour post oocyte retrieval | No | |
Secondary | Miscarriage rate | Up to 12 weeks post embryo-transfer | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03607409 -
Role of Inhibin A as Biomarker for Ovarian Response for IVF Treatment
|
||
Recruiting |
NCT02312076 -
GnRHa for Luteal Phase Support in Long GnRHa Protocol Cycles
|
Phase 4 | |
Terminated |
NCT02161861 -
Improvement of IVF Fertilization Rates, by the Cyclic Tripeptide FEE - Prospective Randomized Study
|
N/A | |
Completed |
NCT03287479 -
Comparison of a Semi-automated Closed Vitrification System (Gavi®) With a Manual Open Vitrification Sytem (Cryotop®)
|
N/A | |
Terminated |
NCT03522350 -
Randomized Trial Comparing EmbryoScope With EmbryoScope+.
|
N/A | |
Completed |
NCT04496284 -
Embryo Transfer Outcomes After Vitrification With Slush Nitrogen Compared to Liquid Nitrogen
|
N/A | |
Completed |
NCT03623659 -
pArtiaL zonA pelluciDa Removal by assisteD hatchINg of Blastocysts
|
N/A | |
Completed |
NCT03895099 -
New Ovarian Stimulation With Random Start, Use of Progestin Protocol for Oocyte Donors
|
Phase 3 | |
Active, not recruiting |
NCT04142112 -
Randomized, Standard-Controlled, Study to Evaluate the Ohana IVF Sperm Preparation Kit, SPeRtility IVF Next Generation
|
N/A | |
Completed |
NCT03152643 -
Cumulative Live Birth Rates After Cleavage-stage Versus Blastocyst-stage Embryo Transfer
|
N/A | |
Recruiting |
NCT03683771 -
Assessment of Endometrial Pattern and Sub-endometrial Vascularity in ICSI Outcome
|
||
Recruiting |
NCT03161119 -
Comparing Two Different Embryo Transfer Catheters
|
N/A | |
Completed |
NCT04108039 -
Micronized Progesterone vs Gonadotropin-releasing Hormone (GnRH) Antagonist in Freeze-all IVF Cycles.
|
N/A | |
Completed |
NCT03678818 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin A (ICSI-LA)
|
N/A | |
Completed |
NCT03678558 -
Oocyte Vitrification Aided With Cytochalasin B
|
N/A | |
Completed |
NCT03677492 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin D ( ICSI-CD)
|
N/A | |
Completed |
NCT03678584 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Chaetoglobosin A ( ICSI-CA)
|
N/A | |
Completed |
NCT03678610 -
Handling Medium for ICSI With Ionomycin and Latrunculin A
|
N/A | |
Completed |
NCT03678571 -
Oocyte Vitrification Aided With Latrunculin A
|
N/A | |
Completed |
NCT03678597 -
Supplementing Intracytoplasmic Sperm Injection Handling Medium With Latrunculin B ( ICSI-LB)
|
N/A |