InfertilityNCT03861715
Single Follicular Dexarelix for LH Suppression During Ovarian Stimulation in Oocyte Donors.
An observational study of Infertility and Premature Ovarian Failure, run by Assisting Nature at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Premature Ovarian Failure
- What is being tested?
- live birth rate
- How many people
- 180 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2017to Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 34 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women 20-34 years old who follow COS with a single GnRH antagonist Degarelix or multidose GnRH antagonist Ganirelix.
Who may be able to join
- 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).
Who cannot join
- 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;
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- endometriosis stage III/IV;
- history of recurrent miscarriage;
- severe OHSS in a previous stimulation cycle or any contraindication for the use of gonadotrophins.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Assisting Nature
Thessaloniki, 57001
Evaggelos Papanikolaou, MD, PhD, 00302310424294, papanikolaou@assistingnature.gr
Robert Najdecki, MD, PhD, 00306936646464, rnajdecki@assistingnature.gr
About this study
Official title: Single Follicular Dexarelix, a New Long Acting GnRH- Antagonist for LH Suppression During Ovarian Stimulation in Oocyte Donors. A Randomised Control Trial.
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.
Read the 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.
- Conditions
- Infertility, Premature Ovarian Failure
- Being tested
- live birth rate
- Keywords
- antagonist protocol, degarelix antagonist protocol, degarelix, IVF
- Medical subject headings
- Infertility, Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
live birth rateDiagnostic test
Also called blastulation rate
The blastulation rate and live birth rate according to the protocol of COS
| Study group | Role | What they receive |
|---|---|---|
| Single Dose antagonist Degarelix | The blastocyst formation rate and live birth rates of patients who followed GnRH antagonist protocol with a single dose Degarelix. Receives: Diagnostic Test: live birth rate | |
| Multidose antagonist Ganirelix | The blastocyst formation rate and live birth rates of patients who followed GnRH antagonist protocol with multidose dose Ganirelix. Receives: Diagnostic Test: live birth rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth rate according to stimulation protocol
Live birth rate according to stimulation protocol
Measured: Up to 38 weeks after embryo transfer
Secondary outcomes (1)
Blastulation rate according to stimulation protocol
Blastulation rate according to stimulation protocol
Measured: Up to 6 days post oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2019
- Study startJan 2017
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assisting Nature
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Papanikolaou Evaggelos, Assisting Nature
- Investigators
- Evaggelos Papanikolaou, MD, PhD, Principal investigator, Assisting NatureRobert Najdecki, MD, PhD, Principal investigator, Assisting Nature
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03861715
- Sponsor's protocol ID
- Single-VS-multiple dose- AN007
- Status last verified
- Oct 2020
- First submitted
- 1 Mar 2019
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Follicular Dexarelix, a New Long Acting GnRH- Antagonist for LH Suppression During Ovarian Stimulation in Oocyte Donors. A Randomised Control Trial.
- ClinicalTrials.gov ID
- NCT03861715
- Acronym / sponsor ID
- Single-VS-multiple dose- AN007
- Conditions
- Infertility, Premature Ovarian Failure
- Keywords
- antagonist protocol, degarelix antagonist protocol, degarelix, IVF
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Assisting NatureUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 4 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Dose antagonist Degarelix | – | Diagnostic Test: live birth rateThe blastocyst formation rate and live birth rates of patients who followed GnRH antagonist protocol with a single dose Degarelix. |
| Multidose antagonist Ganirelix | – | Diagnostic Test: live birth rateThe blastocyst formation rate and live birth rates of patients who followed GnRH antagonist protocol with multidose dose Ganirelix. |
Who may qualify
- Ages
- 20 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women 20-34 years old who follow COS with a single GnRH antagonist Degarelix or multidose GnRH antagonist Ganirelix.
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| live birth rateAlso: blastulation rateThe blastulation rate and live birth rate according to the protocol of COS | Diagnostic test | Multidose antagonist Ganirelix, Single Dose antagonist Degarelix |
Primary outcome
Live birth rate according to stimulation protocol
Time frame: Up to 38 weeks after embryo transfer
Live birth rate according to stimulation protocol
1 secondary outcome
Blastulation rate according to stimulation protocol
Time frame: Up to 6 days post oocyte retrieval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evaggelos Papanikolaou, MD, PhD principal investigator
Assisting Nature
Robert Najdecki, MD, PhD principal investigator
Assisting Nature
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and Premature Ovarian Failure, run by Assisting Nature at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evaggelos Papanikolaou, MD,PhD (00302310424294, drvagpapanikolaou@yahoo.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth rate according to stimulation protocol (time frame: Up to 38 weeks after embryo transfer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.