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)

Regionshospitalet Viborg, Skive

Status and phase: Completed; Phase 4

Conditions: Controlled Ovarian Stimulation; Infertility

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01339299

700642-603

2009-009375-35 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

recombinant luteinizing hormone

Experimental group

Description:

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)

Treatment:

Drug: recombinant luteinizing hormone (r-LH)

recombinant human chorionic gonadotrofin

Active Comparator group

Description:

25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )

Treatment:

Drug: recombinant human chorionic gonadotropin (r-hCG)