Clinical trial NCT03684421: Clinical and Live Birth Rates After Following Long Antagonist Protocol Versus Classical Antagonist Protocol
Official title: Clinical and Live Birth Rates After Controlled Ovarian Stimulation With the Long Antagonist Protocol Versus Classical Antagonist Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy, Ovarian
Keywords: Long Antagonist
Classical Antagonist
live birth rate
clinical pregnancy rate
ovarian stimulation
IVF
Lead sponsor: Assisting Nature
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women 18- 39 years old who follow COS with the Long Antagonist Protocol or with Long Agonist Protocol

Brief summary: A randomized prospective study of the evaluation of the clinical IVF results after following Long Antagonist protocol for controlled ovarian stimulation versus following classical antagonist protocol

Detailed description: A randomized prospective study of administration of Degarelix in late luteal phase of women undergoing ovarian stimulation for IVF: Single dose of Degarelix (24mg, 16mg or 12 mg), on day 24th of previous luteal face cycle, was administered. The Clinical Pregnancy and Live Birth Rates were estimated for this group of patients, comparing to the rates of the group which followed classical antagonist protocol. The number of the formed blastocysts in each group is measured, as well.

Eligibility criteria: Inclusion Criteria:

* primary infertility
* age 18-39 years; body mass index (BMI) 18-29kg/m2;
* regular menstrual cycle of 26-35days,
* 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;
* history of being a 'poor responder',
* defined as \>20 days of gonadotrophin in a previous stimulation cycle, or any previous cancellation of a stimulation cycle due to limited follicular response, or development of less than 4 follicles 15 mm in a previous stimulation cycle; history of recurrent miscarriage; severe OHSS in a previous stimula- tion cycle or any contraindication for the use of gonadotrophins.

Primary outcomes:
measure: Clinical Pregnancy Rate according to stimulation protocol
timeFrame: 6 weeks to 42 weeks after embryo transfer
measure: Number of formed blastocysts
timeFrame: 5 days after the OPU day
Secondary outcomes:
measure: Live Birth Rate according to stimulation protocol
timeFrame: 6 weeks to 42 weeks after embryo transfer
Other outcomes:
Locations:
city: Thessaloniki
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: