Clinical trials: Assisted Reproductive Technology
Controlled Ovarian Simulation
Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Pan-Asian Women
To demonstrate non-inferiority of FE 999049 compared with GONAL-F with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation.
- Trial name
- NCT03296527
- Testing
- Follitropin alfa, Follitropin delta
- Where
- 26 sites in China, South Korea and 2 more
- Volunteers
- 1,011 people
- Sponsor
- Ferring Pharmaceuticals
Assisted Reproduction
Identify Effective Doses of LY01021 in Controlled Ovarian Hyperstimulation (COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)
This is a multicentre, open-label, dose-finding, phase 2 study that will recruit approximately 90 female subjects undergoing COH for in vitro fertilization (IVF) or intracytoplasmic single sperm injection (ICSI).
- Trial name
- NCT07236476
- Testing
- LY01021
- Where
- China
- Volunteers
- 90 people
- Sponsor
- Luye Pharma Group Ltd.
Infertility, Ovulation Induction
Convenience and Safety of Assisted Reproductive Technology Procedures Using a Gonal-F Filled by Mass (Fbm) Liquid Formulation Applied by Pen for Ovulation Induction and In-vitro Fertilization
This was a prospective, open-label, non-comparative, Phase IIIb trial to assess the convenience, safety and efficacy of the new Gonal-F fbm [recombinant follicle stimulating hormone (r-FSH)] liquid formulation, in common setting…
- Conditions
- Infertility, Ovulation Induction, In-Vitro Fertilization
- Trial name
- Prestyje (NCT01183143)
- Testing
- GONAL-f®
- Where
- Germany
- Volunteers
- 215 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, Female
Multicenter, Randomized, Open Label, Parallel Study to Evaluate the Efficacy & Safety of IVF-M HP Inj. vs. Menopur® Inj.
The objective of this study was to demonstrate the non-inferiority of IVFM HP Inj. by evaluating its efficacy versus Menopur® Inj.
- Trial name
- NCT02458768
- Testing
- IVF-M HP Inj., Menopur® Inj.
- Volunteers
- 112 people
- Sponsor
- LG Life Sciences
Infertility
CONSORT Randomized Controlled Trial in Assisted Reproductive Technology
The overall objective of this trial is to compare the ovarian response in assisted reproductive technology (ART) subjects administered GONAL f® according to the 'Consistency in recombinant follicle stimulating hormone [r-FSH]…
- Trial name
- NCT00829244
- Testing
- GONAL f® prefilled pen
- Where
- Switzerland
- Volunteers
- 200 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Controlled Ovarian Stimulation
To Compare and Evaluate the Efficacy and Safety of Ganilever PFS(Prefilled Syringe) and Orgalutran®
to compare and evaluate the efficacy and safety of Ganilever PFS and Orgalutran® in infertility women for assisted reproductive technologies
- Trial name
- NCT03051087
- Testing
- Ganirelix acetate
- Where
- 2 sites in South Korea
- Volunteers
- 255 people, healthy volunteers welcome
- Sponsor
- LG Life Sciences
Infertility, Ovulation Induction
A Randomised, Phase II, Comparative Study With a Parallel Control for Evaluating the Efficacy and Safety of Combined Treatment of Lutropin Alpha and Recombinant Human Luteinizing Hormone in the Middle of the Controlled Ovarian Stimulation Follicular Phase in Women With Reduced Ovarian Reserve
This was a prospective, randomized, Phase II, comparative study with a parallel control for evaluating the efficacy and safety of combined treatment of recombinant human follicle stimulating hormone (r-hFSH) and recombinant human…
- Trial name
- NCT01110707
- Testing
- Recombinant human follicle stimulating hormone (r-hFSH), Recombinant human luteinizing hormone (r-hLH)
- Where
- Spain
- Volunteers
- 131 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Reproductive Issues, Reproductive Disorder
An Observational Study of Follitropin Alpha Biosimilar: the Real-world Data
Aim to investigate the efficacy of follitropin alpha biosimilar therapy (Primapur®) in nonselected real-world population.
- Conditions
- Reproductive Issues, Reproductive Disorder, Fertility Disorders, Fertility Issues
- Trial name
- NCT04854707
- Testing
- Follitropin Alfa, Follicle Stimulating Hormone/Luteinizing Hormone
- Where
- 35 sites in Russia
- Volunteers
- 5,484 people
- Sponsor
- IVFarma LLC
Controlled Ovarian Stimulation
A Trial to Investigate the Efficacy and Safety of FE 999302 as add-on Treatment to Follitropin Delta (REKOVELLE) in Women Undergoing Controlled Ovarian Stimulation.
The purpose of this phase 2 dose-ranging trial is to investigate the effects of FE 999302 on parameters influencing pregnancy rates in women undergoing Controlled Ovarian Stimulation (COS) with follitropin delta in a long…
- Trial name
- RAINBOW (NCT03564509)
- Testing
- FE 999302 (1 μg) and follitropin delta, FE 999302 (2 μg) and follitropin delta, FE 999302 (4 μg) and follitropin delta
- Where
- 20 sites in Belgium, Czechia and 3 more
- Volunteers
- 620 people
- Sponsor
- Ferring Pharmaceuticals
Assisted Reproductive Techniques, Reproductive Technology, Assisted
PERgoveriS In Stratified Treatment for Assisted Reproductive Technique
This is a multicenter, multi-national, randomized, open-label comparative trial. After screening, the subjects will start down-regulation treatment on Day 21-22 of the cycle.
- Trial name
- PERSIST (NCT01297465)
- Testing
- Gonal-f®, Pergoveris®, Recombinant human chorionic gonadotropin (r-hCG)
- Where
- 23 sites in Denmark, Finland and 9 more
- Volunteers
- 202 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Infertility
Comparison of MENOPUR Liquid and Powder in Women Undergoing Assisted Reproductive Technology (ART)
Development of multiple follicles and pregnancy in ovulatory women undergoing controlled ovarian stimulation as part of an assisted reproductive technology (ART) cycle.
- Trial name
- CLARA (NCT04163458)
- Testing
- MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL, MENOPUR powder and solvent for solution for injection, 75 IU
- Where
- 20 sites in United States
- Volunteers
- 405 people
- Sponsor
- Ferring Pharmaceuticals
Infertility, Female
A Randomised Trial Comparing the Ovarian Response of a Starting Dose of Either 10 μg or 15 μg Follitropin Delta (FE 999049) to a Starting Dose of Either 150 IU or 225 IU Follitropin Alfa (GONAL-F) in Conventional Regimens in China
This is a phase 3b clinical trial with follitropin delta (FE 999049) and Gonal-F. The trial is a randomised, controlled, assessor-blind, parallel groups, multicentre trial comparing the ovarian response of a starting dose of…
- Trial name
- COCO (NCT06173869)
- Testing
- FE 999049, GONAL-F
- Where
- 11 sites in China
- Volunteers
- 301 people
- Sponsor
- Ferring Pharmaceuticals
Female Infertility
Recombinant Follicle-stimulating Hormone in Treatment for Infertility
This is a randomized multi-centre, assessor-blind, parallel-group study to be conducted in 250 women in the age group of 20 to 39 years (both inclusive), who are indicated to undergo COS as part of assisted reproductive…
- Trial name
- REFRESH (NCT05266924)
- Testing
- Recombinant Human Follicle Stimulating Hormone 900 IU (66.0 μg) / 1.5mL Solution for Injection in Prefilled Pen
- Where
- India
- Volunteers
- 250 people
- Sponsor
- Bharat Serums and Vaccines Limited
Infertility
Post-Authorisation Study on the Use of Bemfola® in Human Assisted Reproductive Technology
Prospective, non-comparative, multi-centre, multi-country, observational post-authorization study, to correlate predictive factors with number of oocytes in relation to the gonadotropin dose administered using a new r-hFSH…
- Trial name
- NCT02942849
- Testing
- r-hFSH
- Where
- Germany
- Volunteers
- 1,195 people
- Sponsor
- Finox AG
Infertility
GONAL-f CONSORT (Consistency in r-hFSH Starting Doses for Individualised Treatment)
This non-interventional study (NIS) is planned to examine the consistency of the dose recommended by the doctor for the first stimulation day with the dose recommended by the CONSORT calculator.
- Trial name
- NCT01100333
- Testing
- Recombinant human follicle stimulating hormone (r-hFSH)
- Where
- Germany
- Volunteers
- 2,552 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Infertility
Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 2
This trial investigates the immunogenicity of FE 999049 in repeated cycles.
- Trial name
- ESTHER-2 (NCT01956123)
- Testing
- Follitropin Delta (FE 999049), Follitropin Alfa (GONAL-F)
- Where
- 13 sites in Belgium, Brazil and 9 more
- Volunteers
- 513 people
- Sponsor
- Ferring Pharmaceuticals
Infertility, Ovulation Induction
A Clinical Trial to Determine the Effect of Lutropin Alfa on Embryo Quality and Implantation Rate in Advanced Reproductive Age
This is a multicentric, open, randomized, comparative trial aimed to assess the influence of recombinant luteinizing hormone (r-LH) supplementation during controlled ovarian stimulation (COS) in advanced reproductive age in terms…
- Trial name
- NCT01075815
- Testing
- Recombinant human luteinizing hormone (rhLH), Recombinant follicle-stimulating hormone (rFSH)
- Where
- Spain
- Volunteers
- 76 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Infertility
Evidence-based Stimulation Trial With Human rFSH in Europe and Rest of World 1
This trial investigates the effects of FE 999049 compared to GONAL-F.
- Trial name
- ESTHER-1 (NCT01956110)
- Testing
- Follitropin Delta (FE 999049), Follitropin Alfa (GONAL-F)
- Where
- 13 sites in Belgium, Brazil and 9 more
- Volunteers
- 1,329 people
- Sponsor
- Ferring Pharmaceuticals
Female Subjects Undergoing COH in ART to Prevent Early Ovulation
Identify Effective Doses of SHR7280 Tablets in Controlled Ovarian Hyperstimulation (COH) for Female Subjects Undergoing Assisted Reproductive Technology (ART)
This study is a multicentre, open-label phase II dose-finding clinical trial that will recruit approximately 120 female subjects undergoing COH for in vitro fertilization (IVF) or intracytoplasmic single sperm injection (ICSI).
- Trial name
- NCT05082233
- Testing
- SHR7280 tablets
- Where
- China
- Volunteers
- 85 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.