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

Phase 4

Completed

• Conditions: Progesterone Levels; Infertility
• Interventions: 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

• Registration Number: NCT01504139
• Lead Sponsor: Regionshospitalet Viborg, Skive

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.

Study Timeline

• Study First Submitted: 2011-12-28
• Study Start: 2012-01
• Study First Submitted QC: 2012-01-04
• Study First Posted: 2012-01-05
• Primary Completion: 2014-04
• Study Completion: 2014-08
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-09
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 93

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hCG in the late follicular phase + luteal phase	hCG(r-hCG, Ovitrelle, Merck-Serono, Hellerup, Denmark) in the late follicular phase + luteal phase	-
hCG in the follicular phase + luteal phase	hCG(r-hCG, Ovitrelle,Merck-Serono, Hellerup, Denmark) in the follicular phase + luteal phase	-
LH in the luteal phase	LH(r-LH,Luveris, Merck-Serono, Hellerup, Denmark) in the luteal phase	-
vaginal 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	-

Primary Outcome Measures

Name	Time	Method
Levels of progesterone in the mid-luteal phase.	up to 1-1½years.

Trial Locations

Locations (1)

the Fertility clinic, Regional Hospital Skive; 🇩🇰 Skive, Central Jutland, Denmark