Clinical trials: Reproduction
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, 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
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
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
Multi-centre Study to Compare Efficacy and Safety of AFOLIA and Gonal-f in Women for Assisted Reproductive Treatment
Ther purpose of this study is to show equivalence between AFOLIA and Gonal-f® with regard to the number of oocytes retrieved in women for assisted reproductive treatment.
- Trial name
- NCT01121666
- Testing
- Follitropin alfa
- Where
- 16 sites in Austria, Denmark and 4 more
- Volunteers
- 460 people
- Sponsor
- Finox AG
Controlled Ovarian Stimulation
A Study to Assess the Efficacy and Safety of Ganirelix (Orgalutran®) Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for in Vitro Fertilization (IVF) or Intra Cytoplasmatic Sperm Injection (ICSI) (Study 38651)(P05703)
The primary purpose of this study is to assess that ganirelix is safe and well-tolerated in Chinese women and that a controlled ovarian stimulation (COS) protocol combining recombinant follicle stimulating hormone (recFSH) with…
- Trial name
- NCT00725491
- Testing
- ganirelix, triptorelin
- Volunteers
- 259 people
- Sponsor
- Organon and Co
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
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, 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
Reproductive Techniques, Assisted
Effect of a Multivitamin Supplement With Probiotic (Seidivid Ferty4®) on Oocyte Retrieval and Quality
This study evaluates the effect of pretreatment with a multivitamin supplement with probiotics (Seidivid Ferty4®) on oocyte retrieval in normo-responder patients undergoing controlled ovarian hyperstimulation (COH) for oocyte…
- Trial name
- OvoVid (NCT05473039)
- Testing
- Seidivid Ferty4
- Where
- Spain
- Volunteers
- 196 people
- Sponsor
- SEID S.A.
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, 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
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
Contraception
A Study to Evaluate the Pharmacokinetics (PK) of Medroxyprogesterone Acetate Following an Injection of TV-46046 in Healthy Women of Reproductive Age
The primary objective of this study is to evaluate and compare the pharmacokinetic profile of Medroxyprogesterone acetate following subcutaneous administration of 3 different doses of TV-46046 and a dose of Depo-subQ Provera in…
- Trial name
- NCT04682353
- Testing
- TV-46046, Depo-subQ Provera
- Where
- 3 sites in United States, Dominican Republic
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
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
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
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
Infertility
Efficacy and Safety Study of a Single Injection of SCH 900962 Versus Daily recFSH Injections in Women Undergoing Controlled Ovarian Stimulation (Study P06029)
The purpose of this study is to show that a single injection of SCH 900962/MK-8962 is non-inferior to daily injections of recombinant follicle-stimulating hormone (recFSH) during the first week of ovarian stimulation in terms of…
- Trial name
- PURSUE (NCT01144416)
- Testing
- SCH 900962 / Corifollitropin alfa / Org 36286, RecFSH / follitropin beta
- Volunteers
- 1,424 people
- Sponsor
- Organon and Co
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