Clinical and Live Birth Rates After Following Long Antagonist Protocol Versus Classical Antagonist Protocol

Sponsor

Assisting Nature (Other)

Overall Status

Recruiting

CT.gov ID

NCT03684421

Collaborator

(none)

120

Enrollment

Location

52.4

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pregnancy, Ovarian	Diagnostic Test: Pregnancy Rate

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Clinical and Live Birth Rates After Controlled Ovarian Stimulation With the Long Antagonist Protocol Versus Classical Antagonist Protocol

Actual Study Start Date :

Feb 15, 2017

Anticipated Primary Completion Date :

Jun 30, 2021

Anticipated Study Completion Date :

Jun 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Long Antagonist Protocol Clinical pregnancy rate and live birth rates of patients who followed Long Antagonist Protocol for COS	Diagnostic Test: Pregnancy Rate The clinical pregnancy and live birth rate according to the protocol of COS
Classical Antagonist Protocol Clinical pregnancy rate and live birth rates of patients who followed Classical Antagonist Protocol for COS	Diagnostic Test: Pregnancy Rate The clinical pregnancy and live birth rate according to the protocol of COS

Arm

Intervention/Treatment

Long Antagonist Protocol

Clinical pregnancy rate and live birth rates of patients who followed Long Antagonist Protocol for COS

Diagnostic Test: Pregnancy Rate

The clinical pregnancy and live birth rate according to the protocol of COS

Classical Antagonist Protocol

Clinical pregnancy rate and live birth rates of patients who followed Classical Antagonist Protocol for COS

Diagnostic Test: Pregnancy Rate

The clinical pregnancy and live birth rate according to the protocol of COS

Outcome Measures

Primary Outcome Measures

Clinical Pregnancy Rate according to stimulation protocol [6 weeks to 42 weeks after embryo transfer]
Clinical Pregnancy Rate according to stimulation protocol
Number of formed blastocysts [5 days after the OPU day]
The number of the formed blastocysts in each group

Secondary Outcome Measures

Live Birth Rate according to stimulation protocol [6 weeks to 42 weeks after embryo transfer]
Live Birth Rate according to stimulation protocol

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.