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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helle Olesen Elbaek, Regionshospitalet Viborg, Skive
ClinicalTrials.gov Identifier:
NCT01504139
First received: December 28, 2011
Last updated: March 9, 2015
Last verified: March 2015

December 28, 2011
March 9, 2015
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
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Not Provided
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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.

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. Furthermore the aim is to explore whether the luteal phase can be supported with small daily boluses of hCG without the administration of exogenous P, while maintaining good reproductive outcome.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Progesterone Levels
  • Infertility
  • 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.
 
Completed
93
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 information is only displayed when the study is recruiting subjects
Denmark
 
NCT01504139
M-20110289
Yes
Helle Olesen Elbaek, Regionshospitalet Viborg, Skive
Regionshospitalet Viborg, Skive
Not Provided
Study Director: Helle Olesen Elbaek The Fertility Clinic, Skive Regional Hospital, Denmark
Regionshospitalet Viborg, Skive
March 2015

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