A New Revolutionary 3-Injection- Protocol in Infertile Women

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.

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.

Study Overview

• Status: Unknown
• Conditions: Infertility, Female
• Intervention / Treatment: Diagnostic test: Live birth rate

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 Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Greece
  • Thessaloníki, Greece, 57001
    • Recruiting
    • Assisting Nature

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women aged 22- 39, faced with infertility issues, meeting the above inclusion criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
3-Injection-Protocol Group; 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).	Diagnostic test: Live birth rate; Live Birth Rate and Blastulation Rate according to the protocol of COS; Other Names: Blastulation rate
Multiple-Injection- Protocol Group; 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.	Diagnostic test: Live birth rate; Live Birth Rate and Blastulation Rate according to the protocol of COS; Other Names: Blastulation rate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Live birth rate according to stimulation protocol	Live birth rate according to stimulation protocol	Up to 38 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blastulation rate according to stimulation protocol	Blastulation rate according to stimulation protocol	Up to 6 days post oocyte retrieval

Collaborators and Investigators

• Sponsor: Assisting Nature
• Investigators: Principal Investigator: Evaggelos Papanikolaou, MD,PhD, Assisting Nature; Principal Investigator: Robert Najdecki, MD,PhD, Assisting Nature

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (Actual): March 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 8, 2020
• Last Update Submitted That Met QC Criteria: October 6, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: IVF; infertility; ovarian stimulation; corifollitropin alfa; long antagonist; long acting gonadotropin
• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: 3-Injection-Protocol-AN008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No