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

NCT ID: NCT01504139

Last Updated: 2015-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-08-31

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.

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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.

Conditions

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Progesterone Levels Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hCG in the late follicular phase + luteal phase

Group Type EXPERIMENTAL

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

Intervention Type 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 in the follicular phase + luteal phase

Group Type EXPERIMENTAL

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

Intervention Type 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 in the luteal phase

Group Type EXPERIMENTAL

LH(r-LH,Luveris, Merck-Serono, Hellerup, Denmark) in the luteal phase

Intervention Type DRUG

LH(r-LH, Luveris, Merck-Serono, Hellerup, Denmark) replaces progesterone and estradiol in the luteal phase.

vaginal progesterone and estradiol in the luteal phase

Group Type ACTIVE_COMPARATOR

vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol(Estrofem; Novo Nordisk, Copenhagen, Denmark) in the luteal phase

Intervention Type 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-

Interventions

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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).

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

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-

Intervention Type DRUG

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
Minimum Eligible Age

25 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Regionshospitalet Viborg, Skive

OTHER

Sponsor Role lead

Responsible Party

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Helle Olesen Elbaek

Clinical Director, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helle Olesen Elbaek

Role: STUDY_DIRECTOR

The Fertility Clinic, Skive Regional Hospital, Denmark

Locations

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the Fertility clinic, Regional Hospital Skive

Skive, Central Jutland, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 26209535 (View on PubMed)

Other Identifiers

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M-20110289

Identifier Type: -

Identifier Source: org_study_id

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