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

Primary Purpose

Progesterone Levels, Infertility

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
hCG(r-hCG, Ovitrelle, Merck-Serono, Hellerup, Denmark) in the late follicular phase + luteal phase
hCG(r-hCG, Ovitrelle,Merck-Serono, Hellerup, Denmark) in the follicular phase + luteal phase
LH(r-LH,Luveris, Merck-Serono, Hellerup, Denmark) in the luteal phase
vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol(Estrofem; Novo Nordisk, Copenhagen, Denmark) in the luteal phase
Sponsored by
Regionshospitalet Viborg, Skive
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Progesterone Levels

Eligibility Criteria

25 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • the Fertility clinic, Regional Hospital Skive

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

hCG in the late follicular phase + luteal phase

hCG in the follicular phase + luteal phase

LH in the luteal phase

vaginal progesterone and estradiol in the luteal phase

Arm Description

Outcomes

Primary Outcome Measures

Levels of progesterone in the mid-luteal phase.

Secondary Outcome Measures

Full Information

First Posted
December 28, 2011
Last Updated
March 9, 2015
Sponsor
Regionshospitalet Viborg, Skive
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1. Study Identification

Unique Protocol Identification Number
NCT01504139
Brief Title
The Luteal Phase After GnRHa Trigger - a Proof of Concept Study
Official Title
The Luteal Phase After GnRHa Trigger - a Proof of Concept Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regionshospitalet Viborg, Skive

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progesterone Levels, Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
93 (Actual)

8. Arms, Groups, and Interventions

Arm Title
hCG in the late follicular phase + luteal phase
Arm Type
Experimental
Arm Title
hCG in the follicular phase + luteal phase
Arm Type
Experimental
Arm Title
LH in the luteal phase
Arm Type
Experimental
Arm Title
vaginal progesterone and estradiol in the luteal phase
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
hCG(r-hCG, Ovitrelle, Merck-Serono, Hellerup, Denmark) in the late follicular phase + luteal phase
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
hCG(r-hCG, Ovitrelle,Merck-Serono, Hellerup, Denmark) in the follicular phase + luteal phase
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
LH(r-LH,Luveris, Merck-Serono, Hellerup, Denmark) in the luteal phase
Intervention Description
LH(r-LH, Luveris, Merck-Serono, Hellerup, Denmark) replaces progesterone and estradiol in the luteal phase.
Intervention Type
Drug
Intervention Name(s)
vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol(Estrofem; Novo Nordisk, Copenhagen, Denmark) in the luteal phase
Intervention Description
The usual dose of vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol (Estrofem; Novo Nordisk, Copenhagen, Denmark) is given in the luteal phase-
Primary Outcome Measure Information:
Title
Levels of progesterone in the mid-luteal phase.
Time Frame
up to 1-1½years.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helle Olesen Elbaek
Organizational Affiliation
The Fertility Clinic, Skive Regional Hospital, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
the Fertility clinic, Regional Hospital Skive
City
Skive
State/Province
Central Jutland
ZIP/Postal Code
7800
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26209535
Citation
Andersen CY, Elbaek HO, Alsbjerg B, Laursen RJ, Povlsen BB, Thomsen L, Humaidan P. Daily low-dose hCG stimulation during the luteal phase combined with GnRHa triggered IVF cycles without exogenous progesterone: a proof of concept trial. Hum Reprod. 2015 Oct;30(10):2387-95. doi: 10.1093/humrep/dev184. Epub 2015 Jul 23.
Results Reference
derived

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

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