Long Antagonist Protocol for IVF With Single Luteal Dose of Degarelix

Phase 3

• Conditions: Pregnancy, Ovarian
• Interventions: Drug: Degarelix

• Registration Number: NCT03240159
• Lead Sponsor: Assisting Nature

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2017-02-15
• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-03
• Study First Posted: 2017-08-07
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deg-24mg	Degarelix	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.
Deg-16mg	Degarelix	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.
Deg-12mg	Degarelix	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.

Primary Outcome Measures

Name	Time	Method
LH levels	4 days after injection of Degarelix	Effectively down regulation of follicular LH levels (\<14mIU/ml)/

Trial Locations

Locations (1)

Assisting Nature; 🇬🇷 Thessaloníki, Greece