Clinical trials: Infertility Assisted Reproductive Technology
Infertility
Recombinant FSH Investigation in the Treatment of Infertility With Assisted Reproductive Technology (ART) (RITA-1)
This trial investigates the effects of FE 999049 compared to placebo.
- Trial name
- RITA-1 (NCT03740737)
- Testing
- Follitropin delta
- Where
- 23 sites in United States
- Volunteers
- 579 people
- Sponsor
- Ferring Pharmaceuticals
Infertility, Ovarian Stimulation
A Prospective Study to Evaluate the Addition of Subcutaneous Recombinant Human-Luteinizing Hormone With Recombinant Human-Follicle Stimulating Hormone on Follicular Development in Women Undergoing Ovarian Stimulation for Assisted Reproductive Technologies
In-vitro fertilization (IVF) of human oocytes followed by the replacement of embryo in the uterine cavity has become a well established treatment for female infertility attributable to damaged fallopian tubes, endometriosis or…
- Trial name
- NCT01121991
- Testing
- Recombinant Human-Luteinizing Hormone (Luveris)
- Volunteers
- 55 people
- Sponsor
- EMD Serono
Infertility
Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Japanese Women
To demonstrate non-inferiority of FE 999049 compared to FOLLISTIM with respect to number of oocytes retrieved in Japanese IVF/ICSI patients undergoing controlled ovarian stimulation.
- Trial name
- NCT03228680
- Testing
- Follitropin delta, Follitropin beta
- Where
- 17 sites in Japan
- Volunteers
- 373 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
Progesterone Supplementation in Women Undergoing ART
Clinical Safety Study of the Progesterone Vaginal Ring in Women Undergoing Assisted Reproductive Technology Procedures
The purpose of the study is to assess the safety of Progesterone Vaginal Ring (PVR) in women undergoing fresh embryo transfer (ART).
- Trial name
- SARA (NCT03565211)
- Testing
- Progesterone vaginal ring
- Where
- 15 sites in United States
- Volunteers
- 352 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, 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
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
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
Infertility, Pregnancy
Sexual Absorption of Vaginal Progesterone
The purpose of this study is to determine if sexual intercourse lowers serum progesterone in women using vaginal progesterone gel (Crinone®), and increases serum progesterone in their male sexual partners.
- Trial name
- NCT01959464
- Testing
- Crinone vaginal progesterone gel
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Wake Forest University Health Sciences
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
Infertility, Ovulation Induction
A Phase II Study to Assess the Efficacy and Safety of Luveris® (Lutropin Alfa) in Mid Follicular Phase for Controlled Ovarian Stimulation (COS) in Advanced Reproductive Age
Ovarian reserve is related to chronological age; 35 years of age is the accepted threshold for significant decline in assisted reproductive technologies (ART) success with scarce follicular recruitment and poor oocyte retrieval.
- Trial name
- NCT01079949
- Testing
- r-hLH + r-hFSH, r-hFSH, Recombinant Human Choriogonadotropin (r-hCG)
- Where
- Spain
- Volunteers
- 93 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Infertility
Phase 3 Study to Evaluate the Efficacy and Safety of Pergoveris® in Assisted Reproductive Technology (ESPART)
This is a Phase 3, randomized, controlled, single-blind, multicenter, parallel-arm trial to assess the safety and efficacy of Pergoveris® (recombinant human follicle stimulating hormone [r-hFSH]/recombinant human luteinising…
- Trial name
- ESPART (NCT02047227)
- Testing
- Pergoveris®, GONAL-f®, Recombinant human chorionic gonadotrophin (r-hCG)
- Where
- Germany
- Volunteers
- 939 people
- Sponsor
- Merck KGaA, Darmstadt, Germany