A New Revolutionary 3-Injection- Protocol in Infertile Women

Infertility, Female Clinical Trial

Official title:

A New Revolutionary 3-Injection- Protocol in Infertile Women With a Single Long Acting GnRH Antagonist in the Luteal Phase, a Bolus Gonadotropin Injection in the Early Follicular Phase and a Single Triggering Dose.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03877185
• Other study ID #: 3-Injection-Protocol-AN008
• Status: Recruiting
• Start date: July 1, 2018
• 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

This is a prospective randomised study of the evaluation of the clinical IVF results after following a new revolutionary 3-Injection- Protocol for controlled ovarian stimulation in infertile women.

Description:

A randomized prospective study focusing on infertile women undergoing ovarian stimulation for IVF, using Elonva (corifollitropin alfa) as part of two different stimulation protocols.

Women assigned to Protocol A receive a bolus late luteal dose of Degarelix, a new long acting GnRH antagonist, a sole Elonva injection in the evening of day 3 of the cycle, followed by the administration of a single dose of triggering agent (GnRH agonist or hCG a, according to the individual response).

Women assigned to Protocol B are administered a single dose of Elonva (corifollitropin alfa) on day 2 of the cycle, followed by daily GnRH antagonist doses, fixed on day 7 of the cycle. Ovulation triggering is the same as in group A, with either GnRH agonist or hCG a, accordingly.

Live Birth Rates are estimated for both groups of patients. The number of the formed blastocysts in each group is measured, as well.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 39 Years

Eligibility

Inclusion Criteria:

• primary infertility

• age 22-39 years;

• body mass index (BMI) 18-29kg/m2;

• regular menstrual cycle of 26-35 days,

• 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

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Diagnostic Test:
• Live birth rate
Live Birth Rate and Blastulation Rate according to the protocol of COS

Locations

Country	Name	City	State
Greece	Assisting Nature	Thessaloníki

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