Clinical trial NCT00334425: The Effect of LH-Priming During Early Follicular Phase in IVF Treatment.
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Lead sponsor: Central Jutland Regional Hospital
Sponsor class: OTHER
First posted: 2006-06-07
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Circulatory levels of Estradiol on the day of hCG
Secondary outcomes:
measure: 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
measure: E2 per follicle >14 mm
measure: Total number of oocytes retrieved
measure: fertilization rate
measure: serum hCG > 10 IU/l on day 12-14 after embryo transfer
measure: implantation rate
measure: transferable embryos
measure: Clinical pregnancy rate
measure: Ongoing pregnancy rate
measure: embryo quality
measure: Serum; LH, FSH, Androstenedione, Progesterone, hCG and Inhibin-B. Progesterone seven days after ET day
measure: Intra follicular levels of; endocrine parameters
measure: Endometrial thickness; hCG day (minus 0-2 days)
measure: Total gonadotrophin dose administered
Other outcomes:
Locations:
city: Skive
country: Denmark
facility: Fertilitetsklinikken Sygehus Viborg
Study officials:
affiliation: Fertilitetsklinikken Sygehus Viborg
name: Peter Humaidan, M.D.
role: PRINCIPAL_INVESTIGATOR
References: