Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01304511
Other study ID # P08198
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 2005
Est. completion date December 2007

Study information

Verified date April 2024
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this post-marketing surveillance is to identify problems and questions regarding the safety and efficacy of Orgalutran (Ganirelix)® when used for the prevention of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).


Recruitment information / eligibility

Status Completed
Enrollment 711
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Must be undergoing COH for ART Exclusion Criteria: - Hypersensitivity to the active substance or to any of the excipients - Hypersensitivity to gonadotropin-releasing hormone (GnRH) or any other GnRH analogue - Moderate or severe impairment of renal or hepatic function - Pregnancy or lactation

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Orgalutran


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Organon and Co

Outcome

Type Measure Description Time frame Safety issue
Primary Number of retrieved oocytes by COH based on Per stage approach Baseline to End of Study
Primary Number of Serious Adverse Events Baseline to End of Study
Primary Number of Unlabeled (Unexpected) Adverse Drug Reactions Baseline to End of Study
Primary Number of Labeled Adverse Drug Reactions Baseline to End of Study
Primary Number of Non-serious Adverse Events Baseline to End of Study
Primary Number of Adverse events by drug misuse/abuse or drug-drug interaction Baseline to End of Study
See also
  Status Clinical Trial Phase
Completed NCT04213781 - Interest of Audiovisual Distraction in the Management of Anxiety and Pain During Oocyte Retrieval N/A
Completed NCT00608010 - Day 3 Embryo Cryopreservation: Metabolic and Viability Analysis N/A
Completed NCT03527823 - The Comparison of Granulosa Cell Apoptosis Rates With or Without Luteinizing Hormone Administration in Poor Responders.
Not yet recruiting NCT02971280 - Influence of Heavy Metals Exposure on in Vitro Fertilization (IVF) Outcome N/A
Terminated NCT02990949 - The Impact of the Timing of Trigger on IVF Success N/A
Completed NCT00920361 - Designated Drug Use Investigation 1 of Follistim Injection (Study P06130)(COMPLETED)
Recruiting NCT06134609 - Does Sexual Intercourse Affect the Outcomes of Frozen-thawed Embryo Transfer? N/A
Completed NCT03238833 - Poor Ovarian Responders Undergoing IVF Using Luteal Ovarian Stimulation Versus Follicular Ovarian Stimulation N/A
Withdrawn NCT03062098 - Optimizing the Technique of Embryo Transfer in IVF Using Better Imaging Guidance N/A
Recruiting NCT06410417 - Ejaculation Abstinence Time and Assisted Reproductive Technology Outcomes N/A
Not yet recruiting NCT06385444 - IVF Failure and Pregnancy Loss on Couples' Psychological Stress
Recruiting NCT03700255 - Efficacy of a Simulator Based (PickUpSimTM) Residents' Training Program for Oocyte Retrievals N/A
Recruiting NCT04935658 - Oocyte Retrieval and Virtual Reality (REVPO) N/A
Recruiting NCT03713723 - Cardiac Output Monitoring in IVF Patients
Completed NCT03733912 - Plasticizers and in Vitro Fertilization Outcomes
Not yet recruiting NCT06433518 - BEst Size for Ovulation Triggering in Poseidon 4 Patients (BEST 4 Study)
Completed NCT02323347 - Cut-Off Progesterone Values Deleterious for In Vitro Fertilization and Fresh Embryo Transfer N/A
Completed NCT00750451 - Low Molecular Weight Heparin in Recurrent Implantation Failure N/A
Recruiting NCT04124913 - Oral Dydrogesterone vs. Micronized Vaginal Progesterone for Luteal Phase Support in Frozen-thawed Embryo Transfer Cycles Phase 4
Recruiting NCT06177613 - Benefit of Early Intrauterine Transfer of "Blank" Culture Medium Prior to Transfer of a Thawed Embryo From 1st in Vitro Fertilization N/A