Trial | NCT01504139  Report issue

Official Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    progesterone estradiol recombinant human choriogonadotropin alfa lutropin alpha ...

  • Study Participants

    93
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.
Study Started
Jan 31
2012
Primary Completion
Apr 30
2014
Study Completion
Aug 31
2014
Last Update
Mar 10
2015
Estimate

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-

hCG in the late follicular phase + luteal phase Experimental

hCG in the follicular phase + luteal phase Experimental

LH in the luteal phase Experimental

vaginal progesterone and estradiol in the luteal phase Active Comparator

Criteria 

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
No Results Posted