Clinical trial NCT03693534: Clinical and Live Birth Rates After Following Long Antagonist Protocol Versus Long Agonist Protocol
Official title: Clinical and Live Birth Rates After Controlled Ovarian Stimulation With the Long Antagonist Protocol Versus the Long Agonist Protocol
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy, Ovarian
Keywords: Long Antagonist
Long agonist
clinical pregnancy rate
live birth rate
ovarian stimulation
IVF
Lead sponsor: Assisting Nature
Sponsor class: OTHER
First posted: 2018-10-03
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 prospective study of the evaluation of the clinical IVF (in vitro fertilization) results after following Long Antagonist protocol for Controlled Ovarian Stimulation (COS) versus following Long Agonist protocol

Detailed description: A prospective study of the clinical results in women who followed the Long Antagonist protocol for Controlled Ovarian Stimulation (COS) versus women who followed Long Agonist protocol, in an In Vitro Fertilization (IVF) try. In particular, the Clinical Pregnancy Rates (CPR) and Live Birth Rates (LBR) were estimated for the two groups of patients. The number of the formed blastocysts was also measured in each group of patients.

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 in each group of patients
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: