Long Antagonist Protocol for IVF With Single Luteal Dose of Degarelix
NCT ID: NCT03240159
Last Updated: 2020-10-08
Study Results
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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UNKNOWN
PHASE3
120 participants
INTERVENTIONAL
2017-02-15
2021-06-30
Brief Summary
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Detailed Description
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ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.
On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Deg-24mg
Single dose of Degarelix 24mg, on day 24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels.
ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.
On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
Degarelix
Degarelix 24mg Degarelix 16mg Degarelix 12mg
Active Comparator:
Down regulation of LH, during exposing in three different doses of Degarelix
Deg-16mg
Single dose of Degarelix 16mg, on day 24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels.
ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.
On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
Degarelix
Degarelix 24mg Degarelix 16mg Degarelix 12mg
Active Comparator:
Down regulation of LH, during exposing in three different doses of Degarelix
Deg-12mg
Single dose of Degarelix 12mg, on day 24th of previous luteal face cycle.On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels.
ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.
On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
Degarelix
Degarelix 24mg Degarelix 16mg Degarelix 12mg
Active Comparator:
Down regulation of LH, during exposing in three different doses of Degarelix
Interventions
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Degarelix
Degarelix 24mg Degarelix 16mg Degarelix 12mg
Active Comparator:
Down regulation of LH, during exposing in three different doses of Degarelix
Eligibility Criteria
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Inclusion Criteria
* age 18-39 years; body mass index (BMI) 18-29kg/m2;
* regular menstrual cycle of 26-35days,
* presumed to be ovulatory;
* early follicular- phase serum concentration of FSH within normal limits (1-12 IU/l).
Exclusion Criteria
* women with heart disease, QT prolongation,heart failure
* elevated liver enzymes, liver failure, hepatitis
* women with inflammatory or autoimmune disease
* abnormal karyotype;
* polycystic ovarian syndrome,
* endometriosis stage III/IV;
* history of being a 'poor responder',
* defined as \>20 days of gonadotrophin in a previous stimulation cycle, or any previous cancellation of a stimulation cycle due to limited follicular response, or development of less than 4 follicles 15 mm in a previous stimulation cycle; history of recurrent miscarriage; severe OHSS in a previous stimula- tion cycle or any contraindication for the use of gonadotrophins.
18 Years
39 Years
FEMALE
Yes
Sponsors
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Assisting Nature
OTHER
Responsible Party
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Papanikolaou Evaggelos
Papanikolaou Evaggelos, MD, PhD
Principal Investigators
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Evaggelos Papanikolaou, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assisting Nature
Robert Najdecki, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assisting Nature
Locations
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Assisting Nature
Thessaloniki, , Greece
Countries
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Central Contacts
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Facility Contacts
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Najdecki
Role: backup
References
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Papanikolaou EG, Yarali H, Timotheou E, Grynberg M, Zafeiratis O, Tournaye H, Najdecki R. A Proof-of-Concept Clinical Trial of A Single Luteal Use of Long-Acting Gonadotropin-Releasing Hormone Antagonist Degarelix in Controlled Ovarian Stimulation for In Vitro Fertilization: Long Antagonist Protocol. Front Endocrinol (Lausanne). 2018 Mar 1;9:25. doi: 10.3389/fendo.2018.00025. eCollection 2018.
Other Identifiers
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Degarelix-AN003
Identifier Type: -
Identifier Source: org_study_id
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