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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Central Jutland Regional Hospital
• Treatments: Menotropins

Criteria

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