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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01339299
First Posted: April 20, 2011
Last Update Posted: November 27, 2013
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.
Information provided by (Responsible Party):
Peter Humaidan, Regionshospitalet Viborg, Skive
  Purpose
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 Intervention Phase
Controlled Ovarian Stimulation Infertility Drug: recombinant luteinizing hormone (r-LH) Drug: recombinant human chorionic gonadotropin (r-hCG) Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Peter Humaidan, Regionshospitalet Viborg, Skive:

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

Enrollment: 100
Study Start Date: October 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Information from the National Library of Medicine

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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
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
Denmark
Fertility Clinic Skive regional Hospital
Skive, Denmark
Sponsors and Collaborators
Regionshospitalet Viborg, Skive
  More Information

Responsible Party: Peter Humaidan, Prof. M.D. D.M.Sc., Regionshospitalet Viborg, Skive
ClinicalTrials.gov Identifier: NCT01339299     History of Changes
Other Study ID Numbers: 700642-603
2009-009375-35 ( EudraCT Number )
First Submitted: April 19, 2011
First Posted: April 20, 2011
Results First Submitted: September 25, 2013
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:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Hormones
Follicle Stimulating Hormone
Chorionic Gonadotropin
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents