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Completed

NCT Number: NCT01339299

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 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.

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Key information

Conditions

Controlled Ovarian Stimulation Genital Diseases Infertility Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Fertility Clinic Skive regional Hospital

Skive, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

recombinant luteinizing hormone (r-LH)

Drug

administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)

Recombinant human chorionic gonadotropin (r-hCG)

Drug

administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)

Primary outcomes

  1. The Oestradiol Concentration on the Day of Ovulation Induction

    Time frame: treatment day 10 to 14

Sponsors and collaborators

Lead sponsor

Regionshospitalet Viborg, Skive

Other

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Apr 20, 2011
Registry last updated
Nov 27, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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