A New Revolutionary 3-Injection- Protocol in Infertile Women

• Conditions: Infertility, Female
• Interventions: Diagnostic Test: Live birth rate

• Registration Number: NCT03877185
• Lead Sponsor: Assisting Nature

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-15
• 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: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3-Injection-Protocol Group	Live birth rate	Women in group A (3-Injection-Protocol Group) receive a bolus late luteal dose of Degarelix, a new long acting GnRH antagonist, a sole Elonva injection in the early follicular phase followed by the administration of a single dose of triggering agent (GnRH agonist or hCG a, according to the individual response).
Multiple-Injection- Protocol Group	Live birth rate	Women assigned to group B (Multiple- Injection- Protocol Group) are administered a single dose of Elonva (corifollitropin alfa) in the early follicular phase followed by daily GnRH antagonist doses, either fixed on day 6 of the stimulation cycle, or when 2 or 3 follicles over 12-14 mm are present. Ovulation triggering is the same as in group A, with either GnRH agonist or hCG a, accordingly.

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; 🇬🇷 Thessaloníki, Greece