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

This study is currently recruiting participants.

Verified May 2012 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: May 26, 2012

Last verified: May 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

December 28, 2011

Last Updated Date

May 26, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Levels of progesterone in the mid-luteal phase. [ Time Frame: up to 1-1½years. ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01504139 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Hormone Levels (Progesterone)

Intervention ^ICMJE

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-

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

180

Estimated Completion Date

March 2013

Estimated Primary Completion Date

January 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

25 Years to 40 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Helle Olesen Elbaek

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01504139

Other Study ID Numbers ^ICMJE

M-20110289

Has Data Monitoring Committee

Yes

Responsible Party

Helle Olesen Elbaek, Regionshospitalet Viborg, Skive

Study Sponsor ^ICMJE

Regionshospitalet Viborg, Skive

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Regionshospitalet Viborg, Skive

Verification Date

May 2012

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

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