Clinical trials: Intracytoplasmic Sperm Injection
Ovarian Stimulation
Lutropin Alfa in Women at Risk of Poor Response
Evaluate the effectiveness of adding lutropin alfa (recombinant human luteinizing hormone [r-hLH]) in the middle of the follicular phase compared to no addition, in infertile women at risk of poor response stimulated with…
- Trial name
- NCT01112358
- Testing
- r-FSH, r-hLH, Analogous GnRH antagonist
- Where
- Spain
- Volunteers
- 58 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
In Vitro Fertilization
EXpression PRofile Endometrium Samples Study
This is a Phase IV, pilot, open-label, national, multi-centric study planned to determine the gene expression profiles and histologic changes of the endometrial tissue before and after stimulation with Gonal-f®.
- Trial name
- EXPRESS (NCT01210144)
- Testing
- Gonal -f® [r-hFSH], Ovitrelle® [r-hCG alfa], Gonadotropin-releasing hormone (GnRH) Agonist
- Where
- France
- Volunteers
- 27 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Infertility
An Observational Study to Evaluate Efficacy, Safety and Clinical Outcomes of Currently Used Pharmaceutical Therapies for Controlled Ovarian Stimulation in Assisted Reproductive Techniques
Human gonadotrophins have been successfully used for the treatment of infertility for more than 30 years. This observational study is being conducted to evaluate the efficacy and safety of the gonadotropins used for controlled…
- Trial name
- ESCORT (NCT01149070)
- Where
- Hungary
- Volunteers
- 10,103 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Controlled Ovarian Stimulation
Trial to Assess the Pattern of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation (IVF) or Intracytoplasmic Sperm Injection (ICSI) Procedures in Routine Clinical Practice
Study designed to observe the usage patterns, efficacy and safety of REKOVELLE® in women naive to IVF and ICSI, undergoing their first Controlled Ovarian Stimulation (COS) treatment cycle with REKOVELLE® in routine clinical…
- Trial name
- NORSOS (NCT05499052)
- Testing
- REKOVELLE®
- Where
- 9 sites in Denmark, Norway and 2 more
- Volunteers
- 201 people
- Sponsor
- Ferring Pharmaceuticals
Microdissection Testicular Sperm Extraction
Timing of Oocyte Retrieval and Micro Testicular Sperm Extraction
This is a retrospective study to assess outcomes of micro-TESE performed 24 or 48 hours before oocyte retrieval and ICSI.
- Trial name
- NCT07268235
- Where
- Canada
- Volunteers
- 129 people
- Sponsor
- Clinique Ovo
Infertility, Female
Automated Intracytoplasmic Sperm Injection (ICSIA)
The purpose of this research study is to evaluate Overture's automated Intracytoplasmic Sperm Injection (ICSIA) System. ICSIA is an investigational medical device that automates injection of sperm into eggs.
- Trial name
- ICSIA (NCT05633316)
- Testing
- Investigational device named ICSIA, Manual ICSI
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Overture Life
Infertility, Ovulation Induction
To Evaluate the Convenience, Safety and Efficacy of Follitropin Alfa Liquid Pen Compared With Follitropin Beta Liquid Pen
This was a prospective, randomised, open comparative monocentric phase IIIb study to evaluate the convenience, safety and efficacy of follitropin alfa (Gonal-f) liquid pen compared with follitropin beta (Puregon) liquid pen.
- Trial name
- NCT01081639
- Testing
- Follitropin alfa liquid formulation, Follitropin beta liquid formulation
- Volunteers
- 34 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Male Factor Infertility
Effectiveness of the Use of the PICSI Dish (Hyaluronan Microdot) in the Selection of Sperm for Intracytoplasmic Sperm Injection (ICSI)
The purpose of this study is to determine if using microdots of hyaluronan (PICSI) to select sperm for ICSI will result in increased pregnancies especially with men that have a low hyaluronan binding score (HBA).
- Trial name
- NCT00741494
- Testing
- PICSI dish
- Where
- 9 sites in United States
- Volunteers
- 801 people
- Sponsor
- Biocoat
Multifollicular Stimulation
An Observational Study to Compare the Dose of Gonal-fTM FbM Prescribed by the Doctor With the Recommendation of the Dose Calculator Consort and to Evaluate the Ease of Use of Pre-filled Pen of Gonal-fTM FbM Pen
This is a prospective, observational and multicentric study to compare the Gonal-f FbM (filled by mass) dose prescribed by the doctor with the Gonal-f FbM dose determined by the CONSORT (Consistency in r-FSH Starting doses for…
- Trial name
- NCT01080729
- Testing
- Recombinant-follicle stimulating hormone (r-FSH)
- Where
- Belgium
- Volunteers
- 25 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Infertility
TICON-Day 3, Time Lapse Versus Conventional Method in Day 3 Embryo Culture and Assessment
The main purpose of the study was to evaluate the overall clinical value of GERI+ as an integrated embryo culture and assessment system, providing an undisturbed culture environment, continuous monitoring of embryo development…
- Trial name
- TICON (NCT03164551)
- Testing
- GERI+ incubator, Conventional incubator
- Where
- 17 sites in Canada, Denmark and 5 more
- Volunteers
- 408 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Infertility
Automation of Gamete Preparation, Intracytoplasmic Sperm Injection (ICSI), Embryo Culture, and Vitrification
Patients suffering from infertility may seek assisted conception treatment. In a full treatment cycle, the sperm and eggs (gametes) from the intended parents will be looked after by skilled laboratory staff (embryologists) who…
- Trial name
- NCT06074835
- Testing
- Gamete preparation, ICSI, embryo culture and vitrification robot assistant, Routine Manual ICSI Workflow
- Where
- Mexico
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Conceivable Life Sciences
Infertility
Aurora Test for Patients Treated With Recombinant Gonadotropins
This is an observational study. The main aim is to determine the expression of potential biomarker genes in the cumulus cells isolated from individual oocytes in two patient cohorts: recombinant human Follicle Stimulating…
- Trial name
- AURORA-REC (NCT04710264)
- Testing
- AURORA-Rec
- Where
- Belgium
- Volunteers
- 137 people
- Sponsor
- Fertiga, Belgium
Male Infertility, Azoospermia
Evaluating the Safety and Clinical Efficacy of the BAIBYS™ System in Intracytoplasmic Sperm Injection (ICSI)
This study looks at an investigational automated, artificial intelligence (AI)-based sperm selection technology called the BAIBYS™ System.
- Trial name
- Benchmark (NCT06990906)
- Testing
- BAIBYS Sperm selection, Intra cytoplasmatic sperm injection, Conventional manual sperm selection
- Where
- 3 sites in United States, Israel and 1 more
- Volunteers
- 260 people, healthy volunteers welcome
- Sponsor
- BAIBYS Fertility
Controlled Ovarian Stimulation
Study to Assess the Patterns of Use of REKOVELLE® in Naïve Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures
The purpose of this study is to monitor the use in routine clinical practice of REKOVELLE®. This study will collect information from patients who never underwent previous in vitro fertilisation (IVF) or intracytoplasmic sperm…
- Trial name
- PROFILE (NCT03393780)
- Testing
- Follitropin Delta
- Where
- 10 sites in Australia, Austria and 8 more
- Volunteers
- 1,018 people
- Sponsor
- Ferring Pharmaceuticals
Multifollicular Stimulation
An Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to In-vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI)
This is a prospective, observational study in women using Gonal-F filled-by-mass (FbM) in ovarian hyperstimulation as part of their in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment at infertility…
- Trial name
- NCT01075854
- Testing
- Gonal-F (Follitropin alfa)
- Where
- South Korea
- Volunteers
- 1,539 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Infertility
A Study to Evaluate the Ease of Use, Local Tolerance, Safety and Effectiveness of Gonal-f® (Filled-by-mass in a Prefilled Pen)
This is a prospective, open-label, non-comparative, multicentric Phase 4 study to evaluate the ease of use, local tolerance, safety and effectiveness of Gonal-f® (filled-by-mass in a prefilled pen) in subjects undergoing ovarian…
- Trial name
- NCT01115725
- Testing
- Gonal-f® (follitropin alfa)
- Where
- Greece
- Volunteers
- 76 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Male Infertility
Andrositol® TEST as Diagnostic Assay to Predict the Fertilization Potential in IVF
Andrositol® test allows to obtain additional information besides the WHO parameters and to evaluate the semen energetic status. The diagnosis is performed by analyzing the semen at two different time points: before the treatment…
- Trial name
- NCT03677011
- Testing
- Andrositol® Test
- Where
- United States
- Volunteers
- 249 people
- Sponsor
- Lo.Li.Pharma s.r.l
Infertility
A Dose-response Trial Using FE 999049 in Japanese Women Undergoing in Vitro Fertilisation (IVF) / Intracytoplasmic Sperm Injection (ICSI) Treatment
This trial investigates the effects of several doses of FE 999049 in Japanese women undergoing IVF/ICSI treatment.
- Trial name
- NCT02309671
- Testing
- FE 999049, follitropin beta
- Where
- Japan
- Volunteers
- 159 people
- Sponsor
- Ferring Pharmaceuticals
Controlled Ovarian Stimulation
Study to Assess the Design of Use of REKOVELLE® in Women Undergoing In Vitro Fertilisation or Intracytoplasmic Sperm Injection Procedures in Routine Clinical Practice
The aim of the study is to explore how the individualized dosing regimen of REKOVELLE is used in routine clinical practice and to describe the effectiveness and safety of REKOVELLE under real-world conditions.
- Trial name
- DELTA (NCT04503707)
- Testing
- Follitropin Delta
- Where
- 14 sites in France
- Volunteers
- 250 people
- Sponsor
- Ferring Pharmaceuticals