Clinical trial NCT03877185: A New Revolutionary 3-Injection- Protocol in Infertile Women
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility, Female
Keywords: IVF
infertility
long antagonist
long acting gonadotropin
corifollitropin alfa
ovarian stimulation
Lead sponsor: Assisting Nature
Sponsor class: OTHER
First posted: 2019-03-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women aged 22- 39, faced with infertility issues, meeting the above inclusion criteria.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Live birth rate according to stimulation protocol
timeFrame: Up to 38 weeks after embryo transfer
Secondary outcomes:
measure: Blastulation rate according to stimulation protocol
timeFrame: Up to 6 days post oocyte retrieval
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Assisting Nature
Study officials:
affiliation: Assisting Nature
name: Evaggelos Papanikolaou, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assisting Nature
name: Robert Najdecki, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: