The Luteal Phase After GnRHa Trigger - a Proof of Concept Study

This study is currently recruiting participants.
Verified January 2014 by Regionshospitalet Viborg, Skive
Sponsor:
Information provided by (Responsible Party):
Helle Olesen Elbaek, Regionshospitalet Viborg, Skive
ClinicalTrials.gov Identifier:
NCT01504139
First received: December 28, 2011
Last updated: January 3, 2014
Last verified: January 2014

December 28, 2011
January 3, 2014
January 2012
April 2014   (final data collection date for primary outcome measure)
Levels of progesterone in the mid-luteal phase. [ Time Frame: up to 1-1½years. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01504139 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Luteal Phase After GnRHa Trigger - a Proof of Concept Study
The Luteal Phase After GnRHa Trigger - a Proof of Concept Study

The purpose of this study is to investigate levels of progesterone in the luteal phase after various stimulations in the follicular phase and treatment with GnRH antagonist protocol followed by GnRHagonist as induction of ovulation.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hormone Levels (Progesterone)
  • Drug: hCG(r-hCG, Ovitrelle, Merck-Serono, Hellerup, Denmark) in the late follicular phase + luteal phase
    when the follicles are over 12 mm FSH(r-hFSH; Gonal-F, Merck-Serono, Hellerup, Denmark) is replaced by hCG (r-hCG, Ovitrelle,Merck-Serono, Hellerup,Denmark).
  • Drug: hCG(r-hCG, Ovitrelle,Merck-Serono, Hellerup, Denmark) in the follicular phase + luteal phase
    hCG(r-hCG,Ovitrelle,Merck-Serono, Hellerup, Denmark) is given together with FSH(r-hFSH; Gonal-F, Merck-Serono, Hellerup, Denmark) from the beginning of the FSH(r-hFSH; Gonal-F, Merck-Serono, Hellerup, Denmark)stimulation.
  • Drug: LH(r-LH,Luveris, Merck-Serono, Hellerup, Denmark) in the luteal phase
    LH(r-LH, Luveris, Merck-Serono, Hellerup, Denmark) replaces progesterone and estradiol in the luteal phase.
  • Drug: vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol(Estrofem; Novo Nordisk, Copenhagen, Denmark) in the luteal phase
    The usual dose of vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol (Estrofem; Novo Nordisk, Copenhagen, Denmark) is given in the luteal phase-
  • Experimental: hCG in the late follicular phase + luteal phase
    Intervention: Drug: hCG(r-hCG, Ovitrelle, Merck-Serono, Hellerup, Denmark) in the late follicular phase + luteal phase
  • Experimental: hCG in the follicular phase + luteal phase
    Intervention: Drug: hCG(r-hCG, Ovitrelle,Merck-Serono, Hellerup, Denmark) in the follicular phase + luteal phase
  • Experimental: LH in the luteal phase
    Intervention: Drug: LH(r-LH,Luveris, Merck-Serono, Hellerup, Denmark) in the luteal phase
  • Active Comparator: vaginal progesterone and estradiol in the luteal phase
    Intervention: Drug: vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol(Estrofem; Novo Nordisk, Copenhagen, Denmark) in the luteal phase
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
August 2014
April 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • women from the age of 25 up to 40
  • Serum-FSH and serum-LH levels under 12 IU/L
  • Length of period between 25 and 34 days
  • BMI between 18 and 30

Exclusion Criteria:

  • less than 2 ovaries
  • uterine abnormalities
  • PCOS or UL-PCO (more than 11 follicles over 12 mm in 1 ovary
Female
25 Years to 40 Years
Yes
Contact: Helle Olesen Elbaek
Denmark
 
NCT01504139
M-20110289
Yes
Helle Olesen Elbaek, Regionshospitalet Viborg, Skive
Regionshospitalet Viborg, Skive
Not Provided
Not Provided
Regionshospitalet Viborg, Skive
January 2014

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