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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helle Olesen Elbaek, Regionshospitalet Viborg, Skive
ClinicalTrials.gov Identifier:
NCT01504139
First received: December 28, 2011
Last updated: March 9, 2015
Last verified: March 2015
  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
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 ]

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

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

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

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: March 9, 2015
Health Authority: Denmark: Ethics Committee

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

ClinicalTrials.gov processed this record on May 26, 2015