Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Examine Effect of Recombinant Luteinizing Hormone (r-Lh) and Recombinant Human Chorionic Gonadotropin (r-hCG) for Ovarian Stimulation in Assisted Reproduction Techniques (ART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01339299
Recruitment Status : Completed
First Posted : April 20, 2011
Results First Posted : November 27, 2013
Last Update Posted : November 27, 2013
Sponsor:
Information provided by (Responsible Party):
Peter Humaidan, Regionshospitalet Viborg, Skive

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The study is a prospective, randomised, controlled, and non-blinded multi-center pilot study to evaluate endocrine efficacy of recombinant luteinizing hormone versus recombinant human chorionic gonadotropin administered during controlled ovarian stimulation for IVF/ICSI in normogonadotrophic women.

Condition or disease Intervention/treatment Phase
Controlled Ovarian Stimulation Infertility Drug: recombinant luteinizing hormone (r-LH) Drug: recombinant human chorionic gonadotropin (r-hCG) Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Endocrine Efficacy of Either Recombinant Luteinizing Hormone (r-LH) or Low Dose Recombinant Human Chorionic Gonadotropin (r-hCG) Supplementation for Recombinant Follicle Stimulating Hormone (r-FSH) Stimulation in Normogonadotrophic Women Undergoing in Vitro Fertilization (IVF)/Intracytoplasmic Sperm Injection (ICSI) Therapy Following a Long-term Gonadotropin Releasing Hormone (GnRH) Agonist Down Regulation Protocol
Study Start Date : October 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: recombinant luteinizing hormone
150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)
 Drug: recombinant luteinizing hormone (r-LH)
administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)
Active Comparator: recombinant human chorionic gonadotrofin
25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )
 Drug: recombinant human chorionic gonadotropin (r-hCG)
administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The Oestradiol Concentration on the Day of Ovulation Induction [ Time Frame: treatment day 10 to 14 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women who plan to undergo IVF or ICSI treatment
  • Woman's age > 18 years but ≤ 35 years
  • Regular menstrual cycle (25-34 days)
  • BMI 18 to 30 inclusive
  • Signed patient information and informed consent forms

Exclusion Criteria:

  • PCOS
  • More than 2 prior IVF/ICSI attempts
  • Diabetes mellitus, epilepsy, lever-, kidney-, heart- and metabolism disorders, according to the Investigator's assessment.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01339299


Locations
Layout table for location information
Denmark
Fertility Clinic Skive regional Hospital
Skive, Denmark
Sponsors and Collaborators
Regionshospitalet Viborg, Skive
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Peter Humaidan, Prof. M.D. D.M.Sc., Regionshospitalet Viborg, Skive
ClinicalTrials.gov Identifier: NCT01339299    
Other Study ID Numbers: 700642-603
2009-009375-35 ( EudraCT Number )
First Posted: April 20, 2011    Key Record Dates
Results First Posted: November 27, 2013
Last Update Posted: November 27, 2013
Last Verified: April 2011
Keywords provided by Peter Humaidan, Regionshospitalet Viborg, Skive:
COS
ART
Infertility
Additional relevant MeSH terms:
Layout table for MeSH terms
Infertility
Chorionic Gonadotropin
Hormones
 Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents