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NCT03861715·Not applicable·OBSERVATIONAL

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

GanirelixOtherUnknown

Status

Unknown

Phase

Not applicable

Enrollment

180

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Full detailed description

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.

Interventions

Treatment arms and agents.

DIAGNOSTIC_TEST

live birth rate

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

Timeline

From registration to results.

  1. First posted

    Mar 4, 2019

  2. Study start

    Jan 2017

  3. Primary completion

    Dec 2021

  4. Study completion

    Dec 2021

  5. Results posted

    Not reported

  6. Registry updated

    Oct 8, 2020

Outcomes

What the study measures.

Primary outcomes

Live birth rate according to stimulation protocol

Time frame · Up to 38 weeks after embryo transfer

Live birth rate according to stimulation protocol

Secondary outcomes

Blastulation rate according to stimulation protocol

Time frame · Up to 6 days post oocyte retrieval

Blastulation rate according to stimulation protocol

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
34 Years
Sex
FEMALE
Healthy volunteers
Yes

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.

Study locations

1 registered sites.

Greece. Showing up to 24 locations stored in the fast local snapshot.

Assisting Nature

Thessaloniki, Greece

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Ganirelix.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsGanirelix trial dashboard →DatabaseGanirelix database entry →ResearchGanirelix research guide →