NCT01504139

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Regionshospitalet Viborg, Skive · Academic / Other
• Sex: Female
• Age: 25 Years – 40 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Progesterone Levels
• Infertility

Interventions

Type	Name	Description
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-

Timeline

• Start date: 2012-01-01
• Primary completion: 2014-04-01
• Completion: 2014-08-01
• First posted: 2012-01-05
• Last updated: 2015-03-10

Locations

1 site across 1 country: Denmark