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

Pregnancy, Ovarian Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03684421
• Other study ID #: Long-Ant-vs-Ant-AN006
• Status: Recruiting
• Start date: February 15, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2020
• Source: Assisting Nature
• Contact: Evaggelos Papanikolaou, MD,PhD
• Phone: 00302310424294
• Email: drvagpapanikolaou[@]yahoo.gr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy, Ovarian

Intervention

Diagnostic Test:
• Pregnancy Rate
The clinical pregnancy and live birth rate according to the protocol of COS

Locations

Country	Name	City	State
Greece	Assisting Nature	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Assisting Nature

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Pregnancy Rate according to stimulation protocol	Clinical Pregnancy Rate according to stimulation protocol	6 weeks to 42 weeks after embryo transfer
Primary	Number of formed blastocysts	The number of the formed blastocysts in each group	5 days after the OPU day
Secondary	Live Birth Rate according to stimulation protocol	Live Birth Rate according to stimulation protocol	6 weeks to 42 weeks after embryo transfer