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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01504139
• Other study ID #: M-20110289
• Status: Completed
• Phase: Phase 4
• First received: December 28, 2011
• Last updated: March 9, 2015
• Start date: January 2012
• Est. completion date: August 2014

Study information

• Verified date: March 2015
• Source: Regionshospitalet Viborg, Skive
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: August 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Infertility
• Progesterone Levels

Intervention

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).
• 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.
• 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.
• 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-

Locations

Country	Name	City	State
Denmark	the Fertility clinic, Regional Hospital Skive	Skive	Central Jutland

Sponsors (1)

Lead Sponsor	Collaborator
Regionshospitalet Viborg, Skive

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of progesterone in the mid-luteal phase.		up to 1-1½years.	Yes