Infertility
Conditions
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.
Interventions
DRUGMENOPUR; GONAL-F
Sponsors
Central Jutland Regional Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Circulatory levels of Estradiol on the day of hCG | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
| 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 | — |
| 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 | — |
| Clinical pregnancy rate | — |
Countries
Denmark
Contacts
Primary ContactPeter Humaidan, M.D.
Outcome results
None listed