Clinical trials: Assisted Reproduction Technologies
Polycystic Ovary Syndrome
A Study to Explore Correlation Between Symptoms and Signs of Polycystic Ovarian Syndrome (PCOS) and Risk of Over-response to Ovarian Stimulation
This is a Phase IV, prospective, observational, single arm, multicenter trial to identify the population at high risk of overstimulation associated with signs and symptoms of PCOS and examines the utility of 12.5 international…
- Trial name
- ARTIST (NCT02607293)
- Testing
- Gonal-f®, Long GnRH agonist, GnRH antagonist
- Where
- Germany
- Volunteers
- 1,064 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Infertility
A Retrospective Study in Chinese Good Prognosis Patients Undergoing Assisted Reproductive Technology (ART) Treatment
This is a multicenter retrospective study in good prognosis Chinese patients. Data will be collected from infertile women who underwent first in vitro fertilization (IVF)/intra cytoplasmic sperm injection (ICSI) using a…
- Trial name
- FASSION (NCT02889380)
- Testing
- No Intervention
- Where
- 4 sites in China
- Volunteers
- 3,000 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Infertility, Ovulation Induction
SJ-0021 (Gonalef®) Versus Purified Pituitary Gonadotropin (Fertinorm-P®) for Ovulation Induction in Japanese Infertile Women
Efficacy and safety studies in the past have suggested that a starting dose of 75 International Unit (IU) of SJ-0021, and an increase in the dose by 37.5 IU every 7 days, are safe for treatment of subjects with ovulatory…
- Trial name
- NCT01185782
- Testing
- Gonalef® (Follitropin alfa), Purified pituitary gonadotropin (Fertinorm-P®)
- Where
- Japan
- Volunteers
- 300 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
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
Infertility
A Non-interventional Study to Identify the Patients With Severe Luteinizing Hormone Deficiency in the Daily Practice
This non-interventional study is planned to identify the subjects with severe luteinizing hormone (LH) deficiency in the daily practice.
- Trial name
- NCT01112618
- Where
- Germany
- Volunteers
- 3,247 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Infertility
To Investigate REKOVELLE in Chinese Women Undergoing Assisted Reproductive Technologies: Effectiveness, Safety, and Patterns of Use in Real-world Practice
This is a multi-centre prospective non-interventional 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…
- Trial name
- LYCHEE (NCT07029451)
- Where
- 28 sites in China
- Volunteers
- 2,549 people
- Sponsor
- Ferring Pharmaceuticals
Infertility
A Randomized, Multicentre, Open Label, Evaluator Blinded Study to Evaluate Safety and Efficacy of Folitime® of Gemabiotech S.A., Versus Gonal-f ® of Merck Serono, in Patients With Infertility Undergoing ART
This is an open-label, Phase 3, randomized, two arms, multicenter, prospective, experimental study of Folitime® (a new biosimilar formulation of r-hFSH, follitropin alfa) versus the original one (Gonal-f ®).
- Trial name
- NCT02454556
- Testing
- FOLITIME®, Gonal-F®
- Where
- Argentina
- Volunteers
- 106 people
- Sponsor
- Gema Biotech S.A.
Reproductive Techniques, Assisted
Study to Evaluate if the Addition of r-hLH (Luveris®) to FSH From Day 8 of Ovarian Stimulation is Able to Decrease Total FSH Dose and to Improve Cycle Outcome in Infertile Women Undergoing ART, Who Required High FSH Dose in a Previous Cycle
The present study was designed to investigate, in hyporesponder subjects, that required in a previous assisted reproductive technologies (ART) cycle follicle stimulating hormone (FSH) >3500 International Unit (IU), the…
- Trial name
- Luveris in ART (NCT01071200)
- Testing
- Recombinant human Follicle Stimulating Hormone (r-hFSH) and Recombinant human Luteinizing Hormone (r-hLH), r-hFSH
- Where
- Italy
- Volunteers
- 133 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Infertility
Evaluation of Efficacy and Safety of Highly Purified Urofollitropin in Chinese Females Undergoing an Assisted Reproductive Technology (ART) Program
Evaluate the efficacy and safety of of Highly Purified Urofollitropin for Injection Compared to Recombinant Human Follitropin Alfa for Injection in Chinese Females Undergoing an Assisted Reproductive Technology (ART) Program.
- Trial name
- NCT01922193
- Testing
- Highly Purified Urofollitropin, Recombinant Human Follitropin Alfa
- Where
- 11 sites in China
- Volunteers
- 263 people
- Sponsor
- Ferring Pharmaceuticals
Infertility
FSH in GnRH-AntagoniST Controlled Ovarian Hyperstimulation Cycles (FAST)
The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous FSH preparations (Fostimon versus Gonal-F) for controlled ovarian hyperstimulation in a GnRH-antagonist…
- Trial name
- FAST (NCT01969201)
- Testing
- Urofollitrophin, Follitrophin alpha
- Where
- 16 sites in Belgium, Italy and 4 more
- Volunteers
- 710 people
- Sponsor
- IBSA Institut Biochimique SA
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
Infertility
Diafert for Embryo Selection and Fertility Improvement (DESTINy)
Prospective, single-center, single-blind, randomized, controlled, two-arm, interventional study.
- Trial name
- DESTINy (NCT02593513)
- Testing
- Daifert, Control Group
- Where
- Hungary
- Volunteers
- 108 people
- Sponsor
- Forest Laboratories
Infertility
Predictors of Pregnancy Rate in Assisted Reproductive Technology According to Actual Guidelines
Goals: To explore the association of probability of pregnancy with certain prognostic factors in patients undergoing assisted reproductive technology in Russian population according to international and national guidelines.
- Trial name
- IRIS (NCT04249297)
- Testing
- Duphaston® (Dydrogesteron)
- Where
- 52 sites in Kazakhstan, Russia
- Volunteers
- 1,150 people
- Sponsor
- Abbott
Infertility
Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Indian 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
- IRIS (NCT04773353)
- Testing
- Follitropin Delta (FE 999049), Follitropin Alfa (GONAL-F)
- Where
- 12 sites in India
- Volunteers
- 220 people
- Sponsor
- Ferring Pharmaceuticals
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
Infertility, Female
Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-2)
This trial investigates the effects of FE 999049 compared to placebo.
- Trial name
- RITA-2 (NCT03738618)
- Testing
- Follitropin delta
- Where
- 24 sites in United States
- Volunteers
- 588 people
- Sponsor
- Ferring Pharmaceuticals
Infertility
A Trial to Compare the Ovarian Response of REKOVELLE and GONAL-F in Conventional Dosing in Women Undergoing Controlled Ovarian Stimulation
Hormone preparations like REKOVELLE and GONAL-F are used to make the body produce multiple egg sacs, allowing more eggs to be collected from women undergoing infertility treatment.
- Trial name
- ADAPT-1 (NCT05263388)
- Testing
- REKOVELLE (Follitropin Delta), GONAL-F (Follitropin Alfa)
- Where
- 16 sites in Austria, France and 3 more
- Volunteers
- 302 people
- Sponsor
- Ferring Pharmaceuticals
Infertility
An Observational Study of Cetrotide® Gonadotropin-releasing Hormone Antagonist (GnRH Antagonist) With GONAL-f® in Assisted Reproductive Technologies (ART)
This is a multicentric, prospective, observational study on the use of Cetrotide to control the endogenous gonadotrophin levels in Gonal-f stimulated ART treatment cycles in the Asia-Pacific region.
- Trial name
- NCT01109654
- Testing
- Cetrorelix acetate and Follitropin alfa
- Where
- Singapore
- Volunteers
- 2,175 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
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