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COMPLETED Phase 2

Investigation of a Long-Acting Follicle Stimulating Hormone in Infertile Women Undergoing Assisted Reproductive Technology (ART)

NCT00505752 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 520 participants
Start Date 2007-01
Est. Completion 2008-09
Phase Phase 2

Sponsor

Merck KGaA, Darmstadt, Germany

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00505752

The ClinicalTrials.gov registry entry for NCT00505752 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 520 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck KGaA, Darmstadt, Germany, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00505752 reports 1 study location spanning 1 distinct geographic area — top geographies include Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

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. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial