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

• Conditions: Infertility; Premature Ovarian Failure
• Interventions: Diagnostic Test: live birth rate

• Registration Number: NCT03861715
• Lead Sponsor: Assisting Nature

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2019-03-01
• Study First Submitted QC: 2019-03-01
• Study First Posted: 2019-03-04
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 180

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Live birth rate according to stimulation protocol	Up to 38 weeks after embryo transfer	Live birth rate according to stimulation protocol

Secondary Outcome Measures

Name	Time	Method
Blastulation rate according to stimulation protocol	Up to 6 days post oocyte retrieval	Blastulation rate according to stimulation protocol

Trial Locations

Locations (1)

Assisting Nature; 🇬🇷 Thessaloniki, Greece