Status:
UNKNOWN
The Effect of LH-Priming During Early Follicular Phase in IVF Treatment.
Lead Sponsor:
Central Jutland Regional Hospital
Conditions:
Infertility
Eligibility:
FEMALE
18-38 years
Phase:
PHASE4
Brief 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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00334425
Start Date
April 1 2006
Last Update
June 13 2006
Active Locations (1)
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1
Fertilitetsklinikken Sygehus Viborg
Skive, Denmark, 7800