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

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ClinicalTrials.gov Identifier: NCT00334425
Recruitment Status : Unknown
Verified June 2006 by Central Jutland Regional Hospital.
Recruitment status was:  Recruiting
First Posted : June 7, 2006
Last Update Posted : June 13, 2006
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Infertility Drug: MENOPUR; GONAL-F Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: 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 Start Date : April 2006



Primary Outcome Measures :
  1. Circulatory levels of Estradiol on the day of hCG

Secondary Outcome Measures :
  1. 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
  2. E2 per follicle >14 mm
  3. Total number of oocytes retrieved
  4. fertilization rate
  5. serum hCG > 10 IU/l on day 12-14 after embryo transfer
  6. implantation rate
  7. transferable embryos
  8. Clinical pregnancy rate
  9. Ongoing pregnancy rate
  10. embryo quality
  11. Serum; LH, FSH, Androstenedione, Progesterone, hCG and Inhibin-B. Progesterone seven days after ET day
  12. Intra follicular levels of; endocrine parameters
  13. Endometrial thickness; hCG day (minus 0-2 days)
  14. Total gonadotrophin dose administered


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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00334425


Contacts
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Contact: Peter Humaidan, M.D. + 45 89 27 40 11 peter.humaidan@sygehusviborg.dk

Locations
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Denmark
Fertilitetsklinikken Sygehus Viborg Recruiting
Skive, Denmark, 7800
Contact: Peter Humaidan, M.D.    + 45 89 27 40 11    peter.humaidan@sygehusviborg.dk   
Principal Investigator: Peter Humaidan, M.D.         
Sponsors and Collaborators
Central Jutland Regional Hospital
Investigators
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Principal Investigator: Peter Humaidan, M.D. Fertilitetsklinikken Sygehus Viborg

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ClinicalTrials.gov Identifier: NCT00334425     History of Changes
Other Study ID Numbers: 1-2005
First Posted: June 7, 2006    Key Record Dates
Last Update Posted: June 13, 2006
Last Verified: June 2006

Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female