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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 6, 2006
First Posted Date  ICMJE June 7, 2006
Last Update Posted Date June 13, 2006
Study Start Date  ICMJE April 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2006)
Circulatory levels of Estradiol on the day of hCG
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2006)
Circulatory levels of Estradiol hCG day and cycle day 1, 8, the day of oocyte aspiration
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2006)
  • 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
  • implantation rate
  • transferable embryos
  • Clinical pregnancy rate
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2006)
  • 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 and fertilization rate
  • serum hCG > 10 IU/l on day 12-14 after embryo transfer
  • implantation rate
  • Clinical pregnancy rate
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of LH-Priming During Early Follicular Phase in IVF Treatment.
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE Drug: MENOPUR; GONAL-F
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Enrollment  ICMJE
 (submitted: June 6, 2006)
150
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 38 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00334425
Other Study ID Numbers  ICMJE 1-2005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Central Jutland Regional Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Humaidan, M.D. Fertilitetsklinikken Sygehus Viborg
PRS Account Central Jutland Regional Hospital
Verification Date June 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP