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

Infertility Clinical Trial

Official title:

Single Follicular Dexarelix, a New Long Acting GnRH- Antagonist for LH Suppression During Ovarian Stimulation in Oocyte Donors. A Randomised Control Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03861715
• Other study ID #: Single-VS-multiple dose- AN007
• Status: Recruiting
• Start date: January 2017
• Est. completion date: December 2021

Study information

• Verified date: October 2020
• Source: Assisting Nature
• Contact: Evaggelos Papanikolaou, MD,PhD
• Phone: 00302310424294
• Email: drvagpapanikolaou[@]yahoo.gr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 34 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Menopause, Premature
• Premature Ovarian Failure
• Primary Ovarian Insufficiency

Intervention

Diagnostic Test:
• live birth rate
The blastulation rate and live birth rate according to the protocol of COS

Locations

Country	Name	City	State
Greece	Assisting Nature	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Assisting Nature

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Live birth rate according to stimulation protocol	Live birth rate according to stimulation protocol	Up to 38 weeks after embryo transfer
Secondary	Blastulation rate according to stimulation protocol	Blastulation rate according to stimulation protocol	Up to 6 days post oocyte retrieval