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

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

• Registration Number: NCT03693534
• Lead Sponsor: Assisting Nature

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.

Study Timeline

• Study Start: 2017-02-15
• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-03
• 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
Long Antagonist Protocol	Clinical Pregnancy Rate	Clinical Pregnancy Rate, Live Birth Rate and Blastulation Rate of patients who followed Long Antagonist Protocol for Controlled Ovarian Stimulation.
Long Agonist Protocol	Clinical Pregnancy Rate	Clinical Pregnancy Rate and Live Birth Rates and Blastulation Rate of patients who followed Long Agonist Protocol for Controlled Ovarian Stimulation.

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 in each group of patients	5 days after the OPU day	The number of the formed blastocysts in each group of patients according to the COS protocol

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