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

NCT00334425 | Unknown Phase 4

• 1 other identifier: 1-2005
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Circulatory levels of Estradiol on the day of hCG

Secondary Outcomes (14)

• 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

Interventions

MENOPUR; GONAL-F DRUG

Eligibility Criteria

• Age: 18 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• days of menstruation cycle
• Body mass index (BMI) \< 29 kg/m2

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Jutland Regional Hospital: lead

Study Sites (1)

Fertilitetsklinikken Sygehus Viborg

Skive, 7800, Denmark

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

Menotropins; follitropin alfa

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins; Biological Products; Complex Mixtures

Study Officials

• Peter Humaidan, M.D.

  Fertilitetsklinikken Sygehus Viborg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Humaidan, M.D.

CONTACT

+ 45 89 27 40 11; peter.humaidan@sygehusviborg.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 6, 2006
• First Posted: June 7, 2006
• Study Start: April 1, 2006
• Last Updated: June 13, 2006

Record last verified: 2006-06

Locations

DK (1)