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)

Condition(s) targeted: Controlled Ovarian Stimulation; Infertility

Intervention: recombinant luteinizing hormone (r-LH) (Drug); recombinant human chorionic gonadotropin (r-hCG) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Regionshospitalet Viborg, Skive

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.

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 design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome: The Oestradiol Concentration on the Day of Ovulation Induction

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Female.

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.

Fertility Clinic Skive regional Hospital, Skive, Denmark

Starting date: October 2009
Last updated: September 25, 2013