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

Infertility Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00334425
• Other study ID #: 1-2005
• Status: Recruiting
• Phase: Phase 4
• First received: June 6, 2006
• Last updated: June 9, 2006
• Start date: April 2006

Study information

• Verified date: June 2006
• Source: Central Jutland Regional Hospital
• Contact: Peter Humaidan, M.D.
• Phone: + 45 89 27 40 11
• Email: peter.humaidan[@]sygehusviborg.dk
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• MENOPUR; GONAL-F

Locations

Country	Name	City	State
Denmark	Fertilitetsklinikken Sygehus Viborg	Skive

Sponsors (1)

Lead Sponsor	Collaborator
Central Jutland Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulatory levels of Estradiol on the day of hCG
Secondary	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
Secondary	E2 per follicle >14 mm
Secondary	Total number of oocytes retrieved
Secondary	fertilization rate
Secondary	serum hCG > 10 IU/l on day 12-14 after embryo transfer
Secondary	implantation rate
Secondary	transferable embryos
Secondary	Clinical pregnancy rate
Secondary	Ongoing pregnancy rate
Secondary	embryo quality
Secondary	Serum; LH, FSH, Androstenedione, Progesterone, hCG and Inhibin-B. Progesterone seven days after ET day
Secondary	Intra follicular levels of; endocrine parameters
Secondary	Endometrial thickness; hCG day (minus 0-2 days)
Secondary	Total gonadotrophin dose administered