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

NCT ID: NCT03693534

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-15

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Pregnancy, Ovarian

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Long Antagonist Protocol

Clinical Pregnancy Rate, Live Birth Rate and Blastulation Rate of patients who followed Long Antagonist Protocol for Controlled Ovarian Stimulation.

Clinical Pregnancy Rate

Intervention Type DIAGNOSTIC_TEST

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

Long Agonist Protocol

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

Clinical Pregnancy Rate

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Clinical Pregnancy Rate

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Assisting Nature

OTHER

Sponsor Role lead

Responsible Party

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Papanikolaou Evaggelos

Papanikolaou Evaggelos, MD, PhD, Fertility Specialist, Scientific Director at Assisting Nature IVF Clinic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evaggelos Papanikolaou, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assisting Nature

Robert Najdecki, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assisting Nature

Locations

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Assisting Nature

Thessaloniki, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Evaggelos Papanikolaou, MD,PhD

Role: CONTACT

00302310424294

Facility Contacts

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Evaggelos Papanikolaou, MD, PhD

Role: primary

00302310424294

Robert Najdecki, MD, PhD

Role: backup

00306936646464

Other Identifiers

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Long-Antagonist-AN005

Identifier Type: -

Identifier Source: org_study_id

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