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Single Follicular Dexarelix for LH Suppression During Ovarian Stimulation in Oocyte Donors.

A

Assisting Nature

Status

Unknown

Conditions

Infertility
Premature Ovarian Failure

Treatments

Diagnostic Test: live birth rate

Study type

Observational

Funder types

Other

Identifiers

NCT03861715
Single-VS-multiple dose- AN007

Details and patient eligibility

About

A randomized prospective study in the evaluation of the long acting GnRH antagonist Degarelix against the classical multidose regime with Ganirelix for LH suppression during the follicular phase of an ovarian stimulation cycle in oocyte donors.

Full description

A randomized prospective study of the use of single dose of the long acting GnRH antagonist Degarelix for ovarian stimulation cycle in oocyte donors: Ovarian stimulation started on cycle Day2 with gonadotropins 175-300 IU and either GnRH antagonist single dose Degarelix or multidose GnRH antagonist Ganirelix initiated on Day6 of the stimulation cycle. Agonist triggering was used in both groups for oocyte maturation. Blastocyst formation rate and Live Birth Rates were estimated for both groups.

Enrollment

180 estimated patients

Sex

Female

Ages

20 to 34 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • age 20-34 years;
  • body mass index (BMI) 18-29kg/m2;
  • regular menstrual cycle of 26-35 days,
  • AMH levels age appropriate (≥2.3 ng/ml)
  • 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 hereditary genetic diseases;
  • women with heart disease, QT prolongation,heart failure
  • elevated liver enzymes, liver failure, hepatitis
  • women with inflammatory or autoimmune disease
  • abnormal karyotype;
  • endometriosis stage III/IV;
  • history of recurrent miscarriage;
  • severe OHSS in a previous stimulation cycle or any contraindication for the use of gonadotrophins.

Trial design

180 participants in 2 patient groups

Single Dose antagonist Degarelix
Description:
The blastocyst formation rate and live birth rates of patients who followed GnRH antagonist protocol with a single dose Degarelix.
Treatment:
Diagnostic Test: live birth rate
Multidose antagonist Ganirelix
Description:
The blastocyst formation rate and live birth rates of patients who followed GnRH antagonist protocol with multidose dose Ganirelix.
Treatment:
Diagnostic Test: live birth rate

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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