Long Antagonist Protocol for IVF With Single Luteal Dose... | NCT03240159

NCT03240159

Protocol Section

Identification Module

Results Section

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Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Deg-24mg	Active Comparator	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.	Drug: Degarelix
Deg-16mg	Active Comparator	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.	Drug: Degarelix
Deg-12mg	Active Comparator	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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Degarelix	Drug	Degarelix 24mg Degarelix 16mg Degarelix 12mg Active Comparator: Down regulation of LH, during exposing in three different doses of Degarelix	Deg-12mg

Measure	Description	Time Frame
LH levels	Effectively down regulation of follicular LH levels (<14mIU/ml)/	4 days after injection of Degarelix

Eligibility Module

Name	Role	Phone	Extension	Email
Evaggelos Papanikolaou, MD, PhD	Contact	00302310424294		drvagpapanikolaou@yahoo.gr

Name	Affiliation	Role
Evaggelos Papanikolaou, MD, PhD	Assisting Nature	Principal Investigator
Robert Najdecki, MD, PhD	Assisting Nature	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Assisting Nature	Recruiting	Thessaloniki		57001	Greece

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29545772	Derived	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.

ID	Term
D011271	Pregnancy, Ectopic
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases