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

• Conditions: Pregnancy, Ovarian
• Interventions: Diagnostic Test: Pregnancy Rate

• Registration Number: NCT03684421
• Lead Sponsor: Assisting Nature

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.

Study Timeline

• Study Start: 2017-02-15
• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-25
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-10-08
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Classical Antagonist Protocol	Pregnancy Rate	Clinical pregnancy rate and live birth rates of patients who followed Classical Antagonist Protocol for COS
Long Antagonist Protocol	Pregnancy Rate	Clinical pregnancy rate and live birth rates of patients who followed Long Antagonist Protocol for COS

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Live Birth Rate according to stimulation protocol	6 weeks to 42 weeks after embryo transfer	Live Birth Rate according to stimulation protocol

Trial Locations

Locations (1)

Assisting Nature; 🇬🇷 Thessaloniki, Greece