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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01504139
First Posted: January 5, 2012
Last Update Posted: March 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Helle Olesen Elbaek, Regionshospitalet Viborg, Skive
  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
Progesterone Levels Infertility 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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Luteal Phase After GnRHa Trigger - a Proof of Concept Study

Further study details as provided by Helle Olesen Elbaek, Regionshospitalet Viborg, Skive:

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

Enrollment: 93
Study Start Date: January 2012
Study Completion Date: August 2014
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-

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 40 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504139


Locations
Denmark
the Fertility clinic, Regional Hospital Skive
Skive, Central Jutland, Denmark, 7800
Sponsors and Collaborators
Regionshospitalet Viborg, Skive
Investigators
Study Director: Helle Olesen Elbaek The Fertility Clinic, Skive Regional Hospital, Denmark
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Submitted: December 28, 2011
First Posted: January 5, 2012
Last Update Posted: March 10, 2015
Last Verified: March 2015

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