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Long Antagonist Protocol for IVF With Single Luteal Dose of Degarelix

A

Assisting Nature

Status and phase

Unknown
Phase 3

Conditions

Pregnancy, Ovarian

Treatments

Drug: Degarelix

Study type

Interventional

Funder types

Other

Identifiers

NCT03240159
Degarelix-AN003

Details and patient eligibility

About

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

Full 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.

Enrollment

120 estimated patients

Sex

Female

Ages

18 to 39 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 3 patient groups

Deg-24mg
Active Comparator group
Description:
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.
Treatment:
Drug: Degarelix
Deg-16mg
Active Comparator group
Description:
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.
Treatment:
Drug: Degarelix
Deg-12mg
Active Comparator group
Description:
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.
Treatment:
Drug: Degarelix

Trial contacts and locations

1

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Central trial contact

Evaggelos Papanikolaou, MD, PhD

Data sourced from clinicaltrials.gov

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