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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Viborg Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Viborg Hospital
ClinicalTrials.gov Identifier:
NCT00334425
First received: June 6, 2006
Last updated: June 9, 2006
Last verified: June 2006
History of Changes
  Purpose

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 Intervention Phase
Infertility
 Drug: MENOPUR; GONAL-F
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Infertility
Drug Information available for: Menotropins
U.S. FDA Resources

Further study details as provided by Viborg Hospital:

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

Secondary Outcome Measures:
  • 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
  • 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

Estimated Enrollment: 150
Study Start Date: April 2006
  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00334425

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

Locations
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
Viborg Hospital
Investigators
Principal Investigator: Peter Humaidan, M.D. Fertilitetsklinikken Sygehus Viborg
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00334425     History of Changes
Other Study ID Numbers: 1-2005
Study First Received: June 6, 2006
Last Updated: June 9, 2006
Health Authority: Denmark: Danish Medicines Agency

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Menotropins
Fertility Agents, Female
 Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 16, 2012