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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Papanikolaou Evaggelos，Assisting Nature

Tracking Information

First Submitted Date ^ICMJE

September 24, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

January 12, 2017

Estimated Primary Completion Date

August 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Clinical Pregnancy Rate according to stimulation protocol[ Time Frame: 6 weeks to 42 weeks after embryo transfer ]

Clinical Pregnancy Rate according to stimulation protocol

Number of formed blastocysts in each group of patients[ Time Frame: 5 days after the OPU day ]

The number of the formed blastocysts in each group of patients according to the COS protocol

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Diagnostic Test: Clinical Pregnancy Rate
The Clinical Pregnancy, Live Birth Rate and Blastulation Rate according to the protocol of COS

Study Arms

: Long Antagonist Protocol
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 and Live Birth Rates and Blastulation Rate of patients who followed Long Agonist Protocol for Controlled Ovarian Stimulation.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

August 31, 2019

Estimated Primary Completion Date

August 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Greece

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

Papanikolaou Evaggelos，Assisting Nature

Study Sponsor ^ICMJE

Assisting Nature

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Robert Najdecki, MD, PhD Assisting Nature

PRS Account

Assisting Nature

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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