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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention Phase
Hormone Levels (Progesterone)
Drug: hCG(r-hCG, Ovitrelle, Merck-Serono, Hellerup, Denmark) in the late follicular phase + luteal phase
Drug: hCG(r-hCG, Ovitrelle,Merck-Serono, Hellerup, Denmark) in the follicular phase + luteal phase
Drug: LH(r-LH,Luveris, Merck-Serono, Hellerup, Denmark) in the luteal phase
Drug: vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol(Estrofem; Novo Nordisk, Copenhagen, Denmark) in the luteal phase
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Luteal Phase After GnRHa Trigger - a Proof of Concept Study

Resource links provided by NLM:


Further study details as provided by Regionshospitalet Viborg, Skive:

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

Estimated Enrollment: 180
Study Start Date: January 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hCG in the late follicular phase + luteal phase 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).
Experimental: hCG in the follicular phase + luteal phase 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.
Experimental: LH in the luteal phase 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.
Active Comparator: vaginal 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-

  Eligibility

Ages Eligible for Study:   25 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01504139

Contacts
Contact: Helle Olesen Elbaek

Locations
Denmark
the Fertility clinic, Regional Hospital Skive Recruiting
Skive, Central Jutland, Denmark, 7800
Contact: Helle Olesen Elbaek    +4578445709      
Principal Investigator: Helle Olesen Elbaek         
Sponsors and Collaborators
Regionshospitalet Viborg, Skive
  More Information

No publications provided

Responsible Party: Helle Olesen Elbaek, Clinical Director, M.D., Regionshospitalet Viborg, Skive
ClinicalTrials.gov Identifier: NCT01504139     History of Changes
Other Study ID Numbers: M-20110289
Study First Received: December 28, 2011
Last Updated: January 3, 2014
Health Authority: Denmark: The Central research ethics committée

Additional relevant MeSH terms:
Estradiol
Polyestradiol phosphate
Progesterone
Estradiol valerate
Estradiol 17 beta-cypionate
Estradiol 3-benzoate
Chorionic Gonadotropin
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Female
Progestins

ClinicalTrials.gov processed this record on October 02, 2014