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:
Information provided by (Responsible Party):
Peter Humaidan, Regionshospitalet Viborg, Skive
ClinicalTrials.gov Identifier:
NCT01339299
First received: April 19, 2011
Last updated: September 25, 2013
Last verified: April 2011
  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: 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 Regionshospitalet Viborg, Skive:

Primary Outcome Measures:
  • The Oestradiol Concentration on the Day of Ovulation Induction [ Time Frame: treatment day 10 to 14 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 35 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01339299

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

No publications provided

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
Study First Received: April 19, 2011
Results First Received: September 25, 2013
Last Updated: September 25, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Regionshospitalet Viborg, Skive:
COS
ART
Infertility

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Chorionic Gonadotropin
Hormones
Follicle Stimulating Hormone
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on July 22, 2014