Clinical trials: Infertility
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
Hemophilia A
Pharmacokinetic Study of ADVATE Reconstituted in 2 mL Sterile Water for Injection
The purpose of this study is to determine the pharmacokinetics and safety of Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM) reconstituted in 2 mL sterile water for injection (SWFI) and compare with those…
- Trial name
- NCT00952822
- Testing
- Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM). (Antihemophilic factor is also known as Factor VIII)
- Where
- 11 sites in United States
- Volunteers
- 52 people
- Sponsor
- Baxalta now part of Shire
Infertility, Female
Follitropin Delta in Long GnRH Agonist and GnRH Antagonist Protocols (BEYOND)
To compare the efficacy and safety of FE 999049 (follitropin delta) and its personalized dosing algorithm in controlled ovarian stimulation for in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) using a long…
- Trial name
- BEYOND (NCT03809429)
- Testing
- FE 999049 + GnRH agonist (GONAPEPTYL), FE 999049 + GnRH antagonist (CETROTIDE)
- Where
- 16 sites in Austria, Denmark and 5 more
- Volunteers
- 437 people
- Sponsor
- Ferring Pharmaceuticals
Ovulation Induction
A Phase 2 Trial to Evaluate if Corifollitropin Alfa (Org 36286), Followed by a Low Daily Dose of hCG or Recombinant FSH Can Induce Monofollicular Growth in Women With WHO Group II Anovulatory Infertility (P05693)
The primary objective of this trial is to evaluate whether a corifollitropin alfa (Org 36286) regimen applying a single or repeated dose of corifollitropin alfa followed by a low daily dose of Human Chorion Gonadotropin (hCG) or…
- Trial name
- NCT00697255
- Testing
- corifollitropin alfa, recombinant Follicle Stimulating Hormone (recFSH), human Chorion Gonadotropin (hCG)
- Volunteers
- 8 people
- Sponsor
- Organon and Co
Infertility
Predictive Factors for Ovarian Stimulation Using a Fixed Daily Dose of 200 IU Recombinant FSH (Study 142003)(P05696)
The success of assisted reproductive technologies (ART) is critically dependent on optimizing protocols for controlled ovarian stimulation to provide adequate numbers of good quality oocytes and embryos.
- Trial name
- Xpect (NCT00778999)
- Testing
- Marvelon
- Volunteers
- 442 people, healthy volunteers welcome
- Sponsor
- Organon and Co
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
Cervical Dilation, Labor Pain
DilaCheck Cervical Dilation Measurement Trial
Trial to compare the interexaminer agreement between two cervical dilation examinations conducted by Labor and Delivery physicians when using standard methods versus DilaCheck device.
- Conditions
- Cervical Dilation, Labor Pain, Labor Fast, Labor; Irregular
- Trial name
- NCT03440723
- Testing
- DilaCheck, Cervical dilation examination
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Elm Tree Medical Inc.
Infertility
Safety and Efficacy Study in in Vitro Fertilisation (IVF) Patients
The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous hMG preparations when administered to patients undergoing controlled ovarian stimulation for IVF.
- Trial name
- NCT01312766
- Testing
- Menotropins
- Where
- 6 sites in Denmark, France and 3 more
- Volunteers
- 270 people
- Sponsor
- IBSA Institut Biochimique SA
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
Healthy
Bioequivalence Trial of Liquid Versus Freeze-Dried Pergoveris® in Pituitary Suppressed Healthy Premenopausal Female Subjects
Some women cannot have children because they cannot produce enough follicle stimulating hormone (FSH) and luteinising hormone (LH).
- Trial name
- NCT02317809
- Testing
- Liquid pergoveris, Freeze-dried pergoveris
- Where
- Germany
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Merck KGaA, Darmstadt, Germany
Infertility
Phase III Study Comparing Efficacy and Safety of AFOLIA vs Gonal-f® RFF in Women (35 to 42) Undergoing IVF
The purpose of this study is to show that AFOLIA, a recombinant manufactured human follicle stimulating hormone (r-hFSH) has a similar efficacy and safety profile compared to Gonal-f® RFF.
- Trial name
- NCT01687712
- Testing
- AFOLIA, Gonal-f® RFF
- Where
- 22 sites in United States
- Volunteers
- 1,100 people
- Sponsor
- Fertility Biotech AG
Ovulation Induction
Recombinant Follicle Stimulating Hormone (FSH) (Gonal-f®): Use in Ovulation Induction
This is an open-label, prospective, randomized, controlled, multicentric, multinational, phase IV study to evaluate the use of Gonal-f in inducing ovulation in female subjects with chronic anovulation.
- Trial name
- NCT01081626
- Testing
- Recombinant FSH (follitropin alpha)
- Where
- 3 sites in Kuwait, Lebanon and 1 more
- Volunteers
- 310 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Anovulation
Comparison of Anastrozole Verses Clomiphene Citrate in Stimulating Follicular Growth and Ovulation in Infertile Women With Ovulatory Dysfunction
The purpose of this study is to investigate and compare the safety and efficacy of various doses of the aromatase inhibitor (anastrozole) versus clomiphene citrate in stimulating follicular growth and ovulation in infertile women…
- Trial name
- NCT00213148
- Testing
- Anastrozole 1 mg, Anastrozole 5 mg, Anastrozole 10 mg
- Where
- United States
- Volunteers
- 271 people
- Sponsor
- EMD Serono
Corneal Erosion
Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients
The purpose of this study is to measure efficacy and safety with 0.25% SHJ002 sterile ophthalmic solution compared to vehicle in treating corneal erosion in Sjogren's patients.
- Trial name
- NCT06381986
- Testing
- SHJ002, Vehicle
- Where
- 6 sites in Taiwan
- Volunteers
- 116 people
- Sponsor
- Sunhawk Vision Biotech, Inc.
Topical Antisepsis
Test for Pre Operative Skin Preparations
Compare 2 application techniques of ChloraPrep Swabstick--3 swabsticks at once versus 3 swabsticks used sequentially. Hibiclens applied according to the manufacturer's directions.
- Trial name
- NCT00799812
- Testing
- CHG 2% w/v & IPA 70% v/v, swabstick (3 @ once)., CHG 2% w/v & IPA 70% v/v swab applied sequentially, Aqueous CHG 4% w/v applied according to mfr's directions
- Where
- United States
- Volunteers
- 335 people, healthy volunteers welcome
- Sponsor
- C. R. Bard
Infertility
A Korean Post-Marketing Surveillance Study On Pergoveris® (Follitropin Alfa + Lutropin Alfa)
This prospective study collected safety information from more than 600 participants treated with Pergoveris®. During the Post-Marketing Surveillance (PMS) period, data about the participant's background, participant's medical…
- Trial name
- NCT01416987
- Testing
- Pergoveris®
- Where
- 2 sites in South Korea
- Volunteers
- 600 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Infertility, Male
Assessment of TetraSOD® Efficacy to Improve Semen Parameters in Men With Idiopathic Infertility
TetraSOD® is a unique marine phytoplankton (Tetraselmis chuii) SOD-rich ingredient that is grown under patent-protected technology exclusively designed by the company Fitoplancton Marino, S.L. (Spain).
- Trial name
- NCT04864314
- Testing
- Marine microalgae Tetraselmis chuii with high Superoxide Dismutase (SOD) activity
- Where
- 2 sites in Spain
- Volunteers
- 80 people
- Sponsor
- Fitoplancton Marino, S.L.
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