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

Last updated: October 6, 2020
Sponsor: Assisting Nature
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Female Hormonal Deficiencies/abnormalities

Perimenopause

Treatment

N/A

Clinical Study ID

NCT03861715
Single-VS-multiple dose- AN007
  • Ages 20-34
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 ofgonadotrophins.

Study Design

Total Participants: 180
Study Start date:
January 01, 2017
Estimated Completion Date:
December 31, 2021

Study 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.

Connect with a study center

  • Assisting Nature

    Thessaloniki, 57001
    Greece

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.