Long Antagonist Protocol for IVF With Single Luteal Dose of Degarelix

Pregnancy, Ovarian Clinical Trial

Official title:

Long Antagonist Protocol for IVF: a Proof of Concept for a Single Luteal GnRH- Antagonist Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03240159
• Other study ID #: Degarelix-AN003
• Status: Recruiting
• Phase: Phase 3
• Start date: February 15, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2020
• Source: Assisting Nature
• Contact: Evaggelos Papanikolaou, MD, PhD
• Phone: 00302310424294
• Email: drvagpapanikolaou[@]yahoo.gr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

A prospective study of three different doses of Degarelix in late luteal phase of women undergoing ovarian stimulation for IVF:Single dose of Degarelix 24mg, 16mg and 12 mg, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Pregnancy, Ovarian

Intervention

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

Locations

Country	Name	City	State
Greece	Assisting Nature	Thessaloníki

Sponsors (1)

Lead Sponsor	Collaborator
Assisting Nature

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LH levels	Effectively down regulation of follicular LH levels (<14mIU/ml)/	4 days after injection of Degarelix