The Effect of LH-Priming During Early Follicular Phase in IVF Treatment.
Phase 4
- Conditions
- Infertility
- Registration Number
- NCT00334425
- Lead Sponsor
- Central Jutland Regional Hospital
- 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 combinations with HP-HMG and r-FSH.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 150
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Circulatory levels of Estradiol on the day of hCG
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (1)
Fertilitetsklinikken Sygehus Viborg
🇩🇰Skive, Denmark