Pregnancy, OvarianPhase 3NCT03240159
Long Antagonist Protocol for IVF With Single Luteal Dose of Degarelix
A Phase 3 study testing Degarelix in people with Pregnancy, Ovarian, run by Assisting Nature at 1 site in Greece.
Trial summary
A prospective study of three different doses of Degarelix in late luteal phase of women undergoing ovarian stimulation for IVF Read more about this study
- Who is it for?
- Ages 18 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Ovarian
- What is being tested?
- Degarelix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- 15 Feb 2017to 30 Jun 2021
- Phase
- Phase 3
- 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 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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).
Who cannot join
- 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,
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site, 1 recruiting
- Recruiting
Assisting Nature
Thessaloniki, 57001
Robert Najdecki, MD, PhD, 6936646464, rnajdecki@assistingnature.gr
Najdecki
About this study
Official title: Long Antagonist Protocol for IVF: a Proof of Concept for a Single Luteal GnRH- Antagonist Protocol
A prospective study of three different doses of Degarelix in late luteal phase of women undergoing ovarian stimulation for IVF
Read the detailed description
A prospective study of three different doses of Degarelix in late luteal phase of women undergoing ovarian stimulation for IVF:Single dose of Degarelix 24mg, 16mg and 12 mg, on day 24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels.
ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.
On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
- Conditions
- Pregnancy, Ovarian
- Being tested
- Degarelix
- Medical subject headings
- Pregnancy, Ovarian
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DegarelixDrug
Degarelix 24mg Degarelix 16mg Degarelix 12mg
Active Comparator:
Down regulation of LH, during exposing in three different doses of Degarelix
| Study group | Role | What they receive |
|---|---|---|
| Deg-24mg | Active comparator | Single dose of Degarelix 24mg, on day 24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels.
ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.
On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. Receives: Drug: Degarelix |
| Deg-16mg | Active comparator | Single dose of Degarelix 16mg, on day 24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels.
ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.
On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. Receives: Drug: Degarelix |
| Deg-12mg | Active comparator | Single dose of Degarelix 12mg, on day 24th of previous luteal face cycle.On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels.
ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.
On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. Receives: Drug: Degarelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
LH levels
Effectively down regulation of follicular LH levels (<14mIU/ml)/
Measured: 4 days after injection of Degarelix
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start15 Feb 2017
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnancy, OvarianStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 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
- NCT03240159
- Sponsor's protocol ID
- Degarelix-AN003
- Status last verified
- Oct 2020
- First submitted
- 2 Aug 2017
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Papanikolaou EG, Yarali H, Timotheou E, Grynberg M, Zafeiratis O, Tournaye H, Najdecki R. A Proof-of-Concept Clinical Trial of A Single Luteal Use of Long-Acting Gonadotropin-Releasing Hormone Antagonist Degarelix in Controlled Ovarian Stimulation for In Vitro Fertilization: Long Antagonist Protocol. Front Endocrinol (Lausanne). 2018 Mar 1;9:25. doi: 10.3389/fendo.2018.00025. eCollection 2018.
PubMed 29545772
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
- Long Antagonist Protocol for IVF: a Proof of Concept for a Single Luteal GnRH- Antagonist Protocol
- ClinicalTrials.gov ID
- NCT03240159
- Acronym / sponsor ID
- Degarelix-AN003
- Conditions
- Pregnancy, Ovarian
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assisting NatureUniversity, hospital or other
- Study start
- 15 Feb 2017 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 7 Aug 2017 (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 prospective study of three different doses of Degarelix in late luteal phase of women undergoing ovarian stimulation for IVF
Detailed description
A prospective study of three different doses of Degarelix in late luteal phase of women undergoing ovarian stimulation for IVF:Single dose of Degarelix 24mg, 16mg and 12 mg, on day 24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels.
ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels.
On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Deg-24mg | Active comparator | Drug: DegarelixSingle dose of Degarelix 24mg, on day 24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels. ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels. On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. |
| Deg-16mg | Active comparator | Drug: DegarelixSingle dose of Degarelix 16mg, on day 24th of previous luteal face cycle. On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels. ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels. On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. |
| Deg-12mg | Active comparator | Drug: DegarelixSingle dose of Degarelix 12mg, on day 24th of previous luteal face cycle.On day 2 of the cycle: will be measured: LH levels, estradiol levels, and FSH levels. ON day 1 of the stimulation (depending day of the cycle): will be measured: LH levels, estradiol levels, and FSH levels. On day 6 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. On day 8 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. On day 10 of the stimulation( depending day of the cycle):will be measured: LH levels, estradiol levels, and FSH levels. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (9 listed)
- 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;
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 |
|---|---|---|
| DegarelixDegarelix 24mg Degarelix 16mg Degarelix 12mg Active Comparator: Down regulation of LH, during exposing in three different doses of Degarelix | Drug | Deg-12mg, Deg-16mg, Deg-24mg |
Primary outcome
LH levels
Time frame: 4 days after injection of Degarelix
Effectively down regulation of follicular LH levels (<14mIU/ml)/
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.
- Derived from this study: PubMed 29545772Papanikolaou EG, Yarali H, Timotheou E, Grynberg M, Zafeiratis O, Tournaye H, Najdecki R. A Proof-of-Concept Clinical Trial of A Single Luteal Use of Long-Acting Gonadotropin-Releasing Hormone Antagonist Degarelix in Controlled Ovarian Stimulation for In Vitro Fertilization: Long Antagonist Protocol. Front Endocrinol (Lausanne). 2018 Mar 1;9:25. doi: 10.3389/fendo.2018.00025. eCollection 2018.
- 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?
A Phase 3 study testing Degarelix in people with Pregnancy, Ovarian, 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
LH levels (time frame: 4 days after injection of Degarelix). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03240159, which also lists 1 linked publication.
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.