The Effect of LH-Priming During Early Follicular Phase in IVF Treatment.

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.

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