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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Progesterone Levels, Infertility

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hCG in the late follicular phase + luteal phase<br> | Drug: hCG(r-hCG, Ovitrelle, Merck-Serono, Hellerup, Denmark) in the late follicular phase + luteal phase<br>* 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).<br>|
| Experimental: hCG in the follicular phase + luteal phase<br> | Drug: hCG(r-hCG, Ovitrelle,Merck-Serono, Hellerup, Denmark) in the follicular phase + luteal phase<br>* 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.<br>|
| Experimental: LH in the luteal phase<br> | Drug: LH(r-LH,Luveris, Merck-Serono, Hellerup, Denmark) in the luteal phase<br>* LH(r-LH, Luveris, Merck-Serono, Hellerup, Denmark) replaces progesterone and estradiol in the luteal phase.<br>|
| Active Comparator: vaginal progesterone and estradiol in the luteal phase<br> | Drug: vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol(Estrofem; Novo Nordisk, Copenhagen, Denmark) in the luteal phase<br>* The usual dose of vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol (Estrofem; Novo Nordisk, Copenhagen, Denmark) is given in the luteal phase-<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of progesterone in the mid-luteal phase. |  | up to 1-1½years. |