Official Title: “The Effect of LH-Priming During Early Follicular Phase on Ovarian Response and Pregnancy Outcome in GnRHa Down-Regulated Women, Stimulated With Exogenous Gonadotrophins in IVF Treatment”

To evaluate the effect of LH-activity supplementation during the early follicular phase in GnRHa down-regulated women undergoing IVF in terms of S-Estradiol levels on hCG day by comparing different combinations with HP-HMG and r-FSH.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: MENOPUR; GONAL-F

Primary Measures

• Circulatory levels of Estradiol on the day of hCG

Secondary Measures

• Total number of follicles as well as the numbers of follicles <10mm, 10-14 mm, >14mm day during gonadotrophin treatment and at the end of stimulation prior to hCG injection
• E2 per follicle >14 mm
• Total number of oocytes retrieved
• fertilization rate
• serum hCG > 10 IU/l on day 12-14 after embryo transfer
• implantation rate
• transferable embryos
• Implantation rate
• Clinical pregnancy rate
• Ongoing pregnancy rate
• embryo quality
• Serum; LH, FSH, Androstenedione, Progesterone, hCG and Inhibin-B. Progesterone seven days after ET day
• Intra follicular levels of; endocrine parameters
• Endometrial thickness; hCG day (minus 0-2 days)
• Total gonadotrophin dose administered

Inclusion Criteria:

• Females between the ages of 18- 38 years (both included) at the time of randomisation
• Patients for whom treatment with gonadotrophins and GnRH agonist (long protocol) in IVF setting is considered appropriate according to the criteria of the participating centre
• Infertility for at least 1 year before randomisation (except for tubal infertility)
• A maximum of two previous consecutive unsuccessful IVF cycles (i.e. not resulting in an ongoing pregnancy
• 25- 34 days of menstruation cycle
• Body mass index (BMI) < 29 kg/m2

Exclusion Criteria:

• Any clinically significant systemic disease (e.g., insulin dependent diabetes)
• Endocrine or metabolic abnormalities (pituitary, adrenal, thyroid, pancreas, liver, or kidney) which can compromise participation in the study
• Any concomitant medications that would interfere with evaluation of study medications.
• Specifically, any non-study hormonal therapy (except for thyroid medication), prostaglandin inhibitors (NSAIDs, including aspirin) and psychotropic agents (phenothiazine’s, major tranquillisers) at the time of study entry. Note: these medications are disallowed for the study duration.
• Presence of clinically significant uterine fibroids
• Undiagnosed vaginal bleeding
• Tumours of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus
• Pregnancy, lactation or contraindication to pregnancy – must be confirmed by negative urinary pregnancy test at randomisation

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 38 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Viborg Hospital

Overall Clinical Trial Officials and Contacts

Peter Humaidan, M.D. Principal Investigator Fertilitetsklinikken Sygehus Viborg  

Overall Contact: Peter Humaidan, M.D. + 45 89 27 40 11 peter.humaidan@sygehusviborg.dk

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00334425

Study ID Number: 1-2005

ClinicalTrials.gov Identifier: NCT00334425

Health Authority: Denmark: Danish Medicines Agency