Single Follicular Dexarelix for LH Suppression During Ovarian Stimulation in Oocyte Donors.

NCT ID: NCT03861715

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

180 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-31

Study Completion Date

2021-12-31

Brief Summary

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A randomized prospective study in the evaluation of the long acting GnRH antagonist Degarelix against the classical multidose regime with Ganirelix for LH suppression during the follicular phase of an ovarian stimulation cycle in oocyte donors.

Detailed Description

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A randomized prospective study of the use of single dose of the long acting GnRH antagonist Degarelix for ovarian stimulation cycle in oocyte donors: Ovarian stimulation started on cycle Day2 with gonadotropins 175-300 IU and either GnRH antagonist single dose Degarelix or multidose GnRH antagonist Ganirelix initiated on Day6 of the stimulation cycle. Agonist triggering was used in both groups for oocyte maturation. Blastocyst formation rate and Live Birth Rates were estimated for both groups.

Conditions

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Infertility Premature Ovarian Failure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single Dose antagonist Degarelix

The blastocyst formation rate and live birth rates of patients who followed GnRH antagonist protocol with a single dose Degarelix.

live birth rate

Intervention Type DIAGNOSTIC_TEST

The blastulation rate and live birth rate according to the protocol of COS

Multidose antagonist Ganirelix

The blastocyst formation rate and live birth rates of patients who followed GnRH antagonist protocol with multidose dose Ganirelix.

live birth rate

Intervention Type DIAGNOSTIC_TEST

The blastulation rate and live birth rate according to the protocol of COS

Interventions

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live birth rate

The blastulation rate and live birth rate according to the protocol of COS

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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blastulation rate

Eligibility Criteria

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Inclusion Criteria

* age 20-34 years;
* body mass index (BMI) 18-29kg/m2;
* regular menstrual cycle of 26-35 days,
* AMH levels age appropriate (≥2.3 ng/ml)
* 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 hereditary genetic diseases;
* women with heart disease, QT prolongation,heart failure
* elevated liver enzymes, liver failure, hepatitis
* women with inflammatory or autoimmune disease
* abnormal karyotype;
* endometriosis stage III/IV;
* history of recurrent miscarriage;
* severe OHSS in a previous stimulation cycle or any contraindication for the use of gonadotrophins.
Minimum Eligible Age

20 Years

Maximum Eligible Age

34 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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Single-VS-multiple dose- AN007

Identifier Type: -

Identifier Source: org_study_id

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