Long Antagonist Protocol for IVF With Single Luteal Dose of Degarelix

Assisting Nature120 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Pregnancy, Ovarian

Interventions

DegarelixDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 39 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Assisting Nature

Thessaloniki, Greece

RECRUITING

Outcomes

Primary Outcomes

LH levels

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

Time frame: 4 days after injection of Degarelix

Central Contacts

Evaggelos Papanikolaou, MD, PhD

CONTACT

00302310424294 drvagpapanikolaou@yahoo.gr

Data from ClinicalTrials.gov

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