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Completed

NCT Number: NCT01504139

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

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.

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Key information

Conditions

Progesterone Levels Genital Diseases Infertility Urogenital Diseases

Age range

25 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

the Fertility clinic, Regional Hospital Skive

Skive, Central Jutland, 7800, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hCG(r-hCG, Ovitrelle, Merck-Serono, Hellerup, Denmark) in the late follicular phase + luteal phase

Drug

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

Drug

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

Drug

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

Drug

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 outcomes

  1. Levels of progesterone in the mid-luteal phase.

    Time frame: up to 1-1½years.

Sponsors and collaborators

Lead sponsor

Regionshospitalet Viborg, Skive

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 5, 2012
Registry last updated
Mar 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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