Clinical trials: Assisted Reproductive Technology
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
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
Safety and Efficacy of Pre-defined, Fixed Dose of Gonal-f Pen Based on Subject Baseline Characteristics in Subjects Undergoing in Vitro Fertilization (IVF)
Clinical validation of the assisted reproductive technology (ART) treatment guidelines, which determine the optimal dose of recombinant human follicle stimulating hormone (r-hFSH) based on subject baseline…
- Trial name
- CONSORT (NCT00249834)
- Testing
- Gonal-f, Recombinant human chorionic gonadotrophin (r-hCG)
- Where
- France
- Volunteers
- 166 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Infertility
Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)
This is a Phase 2, interventional, prospective, multi-center, randomized, assessor-blind, active-comparator, dose-finding study to evaluate a new investigational long-acting follicle stimulating hormone (FSH) in infertile women…
- Trial name
- NCT00505752
- Testing
- AS900672-Enriched 50 microgram (mcg), AS900672-Enriched 100 mcg, AS900672-Enriched 150 mcg
- Where
- United States
- Volunteers
- 520 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
Polycystic Ovarian Syndrome
Analysis of Two Therapeutic With Cetrotide® in Polycystic Ovarian (PCO) Women in Assisted Reproductive Technology (ART)
This is a randomized open-label study to compare between in-vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI) outcomes of the two regimen of Cetrotide® (Cetrorelix acetate) which are 0.25 milligram (mg) used from…
- Trial name
- ATTAC-PCO (NCT01185704)
- Testing
- Cetrorelix acetate, Recombinant Human Choriogonadotropin (r-hCG), Recombinant human follicle stimulating hormone (r-hFSH)
- Where
- France
- Volunteers
- 136 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Pregnancy, Live Birth
Folic Acid and Zinc Supplementation Trial (FAZST)
The overarching goal of this trial is to determine if an intervention comprising folic acid and zinc dietary supplementation improves semen quality and indirectly fertility outcomes (i.e., live birth rate) among couples trying to…
- Conditions
- Pregnancy, Live Birth, Spontaneous Abortion
- Trial name
- FAZST (NCT01857310)
- Testing
- 5 mg folic acid and 30 mg elemental zinc
- Where
- 4 sites in United States
- Volunteers
- 2,370 people, healthy volunteers welcome
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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, Female
Exploratory Study Assessing Synchronisation of Egg Sacs With Degarelix
The main purpose of this clinical research study is to investigate if degarelix can synchronise the growth of the egg sacs in the ovaries and if degarelix has any effect on the lining of the womb.
- Trial name
- NCT00434122
- Testing
- Degarelix mid-luteal, 2.5 mg
- Where
- 4 sites in Belgium, Czechia and 1 more
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Ferring Pharmaceuticals
Infertility
Menopur Mixed Protocol
The objective of this study was to compare the fertilization rate between the combination of Menopur and Bravelle mixed in the same syringe and Menopur alone, both administered subcutaneously (SC), in subjects undergoing Assisted…
- Trial name
- COMBINE (NCT01417195)
- Testing
- Bravelle, Menopur
- Where
- 10 sites in United States
- Volunteers
- 122 people
- Sponsor
- Ferring Pharmaceuticals