Long Antagonist Protocol for IVF With Single Luteal Dose of Degarelix

NCT03240159 | Unknown Phase 3 DMC

• 1 other identifier: Degarelix-AN003
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective study of three different doses of Degarelix in late luteal phase of women undergoing ovarian stimulation for IVF

Conditions

Pregnancy, Ovarian

Outcome Measures

Primary Outcomes (1)

• LH levels

  Effectively down regulation of follicular LH levels (\<14mIU/ml)/

  4 days after injection of Degarelix

Study Arms (3)

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.

Drug: Degarelix

Interventions

Degarelix DRUG

Degarelix 24mg Degarelix 16mg Degarelix 12mg Active Comparator: Down regulation of LH, during exposing in three different doses of Degarelix

Deg-12mg; Deg-16mg; Deg-24mg

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• primary infertility
• 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).

You may not qualify if:

• women with diabetes and other metabolic disease
• 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.

Sponsors & Collaborators

• Assisting Nature: lead

Study Sites (1)

Assisting Nature

Thessaloniki, 57001, Greece

RECRUITING

Related Publications (1)

• 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.

  PMID: 29545772 DERIVED

MeSH Terms

Conditions

Pregnancy, Ovarian

Interventions

acetyl-2-naphthylalanyl-3-chlorophenylalanyl-1-oxohexadecyl-seryl-4-aminophenylalanyl(hydroorotyl)-4-aminophenylalanyl(carbamoyl)-leucyl-ILys-prolyl-alaninamide

Condition Hierarchy (Ancestors)

Pregnancy, Ectopic; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Evaggelos Papanikolaou, MD, PhD

  Assisting Nature

  PRINCIPAL INVESTIGATOR

• Robert Najdecki, MD, PhD

  Assisting Nature

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evaggelos Papanikolaou, MD, PhD

CONTACT

00302310424294; drvagpapanikolaou@yahoo.gr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Papanikolaou Evaggelos, MD, PhD

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 7, 2017
• Study Start: February 15, 2017
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

GR (1)