Single Follicular Dexarelix for LH Suppression During Ovarian Stimulation in Oocyte Donors.
Single Follicular Dexarelix, a New Long Acting GnRH- Antagonist for LH Suppression During Ovarian Stimulation in Oocyte Donors. A Randomised Control Trial.
1 other identifier
observational
180
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
March 1, 2019
CompletedFirst Posted
Study publicly available on registry
March 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedOctober 8, 2020
October 1, 2020
4.9 years
March 1, 2019
October 6, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Live birth rate according to stimulation protocol
Live birth rate according to stimulation protocol
Up to 38 weeks after embryo transfer
Secondary Outcomes (1)
Blastulation rate according to stimulation protocol
Up to 6 days post oocyte retrieval
Study Arms (2)
Single Dose antagonist Degarelix
The blastocyst formation rate and live birth rates of patients who followed GnRH antagonist protocol with a single dose Degarelix.
Multidose antagonist Ganirelix
The blastocyst formation rate and live birth rates of patients who followed GnRH antagonist protocol with multidose dose Ganirelix.
Interventions
The blastulation rate and live birth rate according to the protocol of COS
Eligibility Criteria
Women 20-34 years old who follow COS with a single GnRH antagonist Degarelix or multidose GnRH antagonist Ganirelix.
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Assisting Naturelead
Study Sites (1)
Assisting Nature
Thessaloniki, 57001, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Evaggelos Papanikolaou, MD, PhD
Assisting Nature
- PRINCIPAL INVESTIGATOR
Robert Najdecki, MD, PhD
Assisting Nature
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Papanikolaou Evaggelos, MD, PhD, Fertility Specialist, Scientific Director at Assisting Nature IVF Clinic
Study Record Dates
First Submitted
March 1, 2019
First Posted
March 4, 2019
Study Start
January 1, 2017
Primary Completion
December 1, 2021
Study Completion
December 1, 2021
Last Updated
October 8, 2020
Record last verified: 2020-10