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NCT00505752 · ClinicalTrials.gov registry record · Phase 2
Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)
A Phase 2 study of Infertility, sponsored by Merck KGaA, Darmstadt, Germany.
- Completed
- Registry status
- Phase 2
- Development phase
- 520
- Enrollment target
- 1
- Study location
NCT00505752: Completed Phase 2 study of Infertility, sponsored by Merck KGaA, Darmstadt, Germany.
NCT00505752 is a Phase 2 study of Infertility that has completed, run by Merck KGaA, Darmstadt, Germany. The registered enrollment target is 520 participants, below the 7,582-participant average among 74 other Infertility trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00505752, a Phase 2 study of Infertility, has completed, sponsored by Merck KGaA, Darmstadt, Germany.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 520 participants
- Enrollment target
- 1
- Study location
Study Summary
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 who are undergoing an assisted reproductive technology (ART) procedure (In vitro fertilization/Intra cytoplasmic sperm injection \[IVF/ICSI\]). This study will compare 3 doses of the investigational drug versus a currently marketed drug follitropin alfa (Gonal-f® revised formulation female \[RFF\] Pen) in regards to the number of fertilized oocytes.
Primary Outcome
Oocytes were fertilized using Intra-cytoplasmic Sperm Injection (ICSI) technique which is an in-vitro fertilization procedure in which a single sperm is injected directly into an egg under a microscope. The appearance of 2PN is the first sign of successful fertilization as observed during in vitro fertilization, and is usually observed after ICSI. The zygote is then termed 2PN.
Conditions Studied
Interventions
- DRUG AS900672-Enriched 50 microgram (mcg)
- DRUG AS900672-Enriched 100 mcg
- DRUG AS900672-Enriched 150 mcg
- DRUG Follitropin alfa 150 international unit (IU)
- DRUG Recombinant human chorionic gonadotropin (r-hCG)
Study Locations (1)
Massachusetts
- Local US Medical Information Office - Rockland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 520 participants |
| Start Date | 2007-01 |
| Est. Completion | 2008-09 |
| Phase | Phase 2 |
What the finished NCT00505752 record still lists
NCT00505752 is an interventional study that assigns participants to a tested intervention. The registered 520 participants enrollment target is mid-sized for trials with a published cap, below the 7,582-participant average among 74 other Infertility trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Infertility appearing as the primary indexed condition, and to 5 interventions - of which AS900672-Enriched 50 microgram (mcg) is the first listed.
NCT00505752 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00505752 about?
NCT00505752 is a clinical study titled "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 who are undergoing an assisted reproductive technology (ART) procedure (...
What is the current status of trial NCT00505752?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 520 participants. The study started on 2007-01. Estimated completion is 2008-09.
What conditions does trial NCT00505752 study?
This clinical trial studies the following conditions: Infertility.
What interventions are being tested in trial NCT00505752?
The interventions under investigation include: AS900672-Enriched 50 microgram (mcg) (DRUG), AS900672-Enriched 100 mcg (DRUG), AS900672-Enriched 150 mcg (DRUG), Follitropin alfa 150 international unit (IU) (DRUG), Recombinant human chorionic gonadotropin (r-hCG) (DRUG).
Who is sponsoring clinical trial NCT00505752?
This trial is sponsored by Merck KGaA, Darmstadt, Germany, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00505752 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00505752's enrollment target sits among peer trials
520 22nd of 74 higher than 53 of 74 other Infertility trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Infertility trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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