Pregnancy, OvarianNCT03693534
Clinical and Live Birth Rates After Following Long Antagonist Protocol Versus Long Agonist Protocol
An observational study of Pregnancy, Ovarian, run by Assisting Nature at 1 site in Greece.
Trial summary
A prospective study of the evaluation of the clinical IVF (in vitro fertilization) results after following Long Antagonist protocol for Controlled Ovarian Stimulation (COS) versus following Long Agonist protocol 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?
- Clinical Pregnancy Rate
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- 15 Feb 2017to 30 Jun 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 18 to 39 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women 18- 39 years old who follow COS with the Long Antagonist Protocol or with Long Agonist Protocol
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,
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- 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
Evaggelos Papanikolaou, MD, PhD, 00302310424294, papanikolaou@assistingnature.gr
Robert Najdecki, MD, PhD, 00306936646464, rnajdecki@assistingnature.gr
About this study
Official title: Clinical and Live Birth Rates After Controlled Ovarian Stimulation With the Long Antagonist Protocol Versus the Long Agonist Protocol
A prospective study of the evaluation of the clinical IVF (in vitro fertilization) results after following Long Antagonist protocol for Controlled Ovarian Stimulation (COS) versus following Long Agonist protocol
Read the detailed description
A prospective study of the clinical results in women who followed the Long Antagonist protocol for Controlled Ovarian Stimulation (COS) versus women who followed Long Agonist protocol, in an In Vitro Fertilization (IVF) try. In particular, the Clinical Pregnancy Rates (CPR) and Live Birth Rates (LBR) were estimated for the two groups of patients. The number of the formed blastocysts was also measured in each group of patients.
- Conditions
- Pregnancy, Ovarian
- Being tested
- Clinical Pregnancy Rate
- Keywords
- Long Antagonist, Long agonist, clinical pregnancy rate, live birth rate, ovarian stimulation, IVF
- Medical subject headings
- Pregnancy, Ovarian
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Pregnancy RateDiagnostic test
The Clinical Pregnancy, Live Birth Rate and Blastulation Rate according to the protocol of COS
| Study group | Role | What they receive |
|---|---|---|
| Long Antagonist Protocol | Clinical Pregnancy Rate, Live Birth Rate and Blastulation Rate of patients who followed Long Antagonist Protocol for Controlled Ovarian Stimulation. Receives: Diagnostic Test: Clinical Pregnancy Rate | |
| Long Agonist Protocol | Clinical Pregnancy Rate and Live Birth Rates and Blastulation Rate of patients who followed Long Agonist Protocol for Controlled Ovarian Stimulation. Receives: Diagnostic Test: Clinical Pregnancy Rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rate according to stimulation protocol
Clinical Pregnancy Rate according to stimulation protocol
Measured: 6 weeks to 42 weeks after embryo transfer
Number of formed blastocysts in each group of patients
The number of the formed blastocysts in each group of patients according to the COS protocol
Measured: 5 days after the OPU day
Secondary outcomes (1)
Live Birth Rate according to stimulation protocol
Live Birth Rate according to stimulation protocol
Measured: 6 weeks to 42 weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- 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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- 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
- NCT03693534
- Sponsor's protocol ID
- Long-Antagonist-AN005
- Status last verified
- Oct 2020
- First submitted
- 24 Sep 2018
- 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
- Clinical and Live Birth Rates After Controlled Ovarian Stimulation With the Long Antagonist Protocol Versus the Long Agonist Protocol
- ClinicalTrials.gov ID
- NCT03693534
- Acronym / sponsor ID
- Long-Antagonist-AN005
- Conditions
- Pregnancy, Ovarian
- Keywords
- Long Antagonist, Long agonist, clinical pregnancy rate, live birth rate, ovarian stimulation, IVF
- Study type
- Observational
- 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
- 3 Oct 2018 (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 the evaluation of the clinical IVF (in vitro fertilization) results after following Long Antagonist protocol for Controlled Ovarian Stimulation (COS) versus following Long Agonist protocol
Detailed description
A prospective study of the clinical results in women who followed the Long Antagonist protocol for Controlled Ovarian Stimulation (COS) versus women who followed Long Agonist protocol, in an In Vitro Fertilization (IVF) try. In particular, the Clinical Pregnancy Rates (CPR) and Live Birth Rates (LBR) were estimated for the two groups of patients. The number of the formed blastocysts was also measured in each group of patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long Antagonist Protocol | – | Diagnostic Test: Clinical Pregnancy RateClinical Pregnancy Rate, Live Birth Rate and Blastulation Rate of patients who followed Long Antagonist Protocol for Controlled Ovarian Stimulation. |
| Long Agonist Protocol | – | Diagnostic Test: Clinical Pregnancy RateClinical Pregnancy Rate and Live Birth Rates and Blastulation Rate of patients who followed Long Agonist Protocol for Controlled Ovarian Stimulation. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women 18- 39 years old who follow COS with the Long Antagonist Protocol or with Long Agonist Protocol
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 |
|---|---|---|
| Clinical Pregnancy RateThe Clinical Pregnancy, Live Birth Rate and Blastulation Rate according to the protocol of COS | Diagnostic test | Long Agonist Protocol, Long Antagonist Protocol |
Primary outcome
Clinical Pregnancy Rate according to stimulation protocol
Time frame: 6 weeks to 42 weeks after embryo transfer
Clinical Pregnancy Rate according to stimulation protocol
Number of formed blastocysts in each group of patients
Time frame: 5 days after the OPU day
The number of the formed blastocysts in each group of patients according to the COS protocol
1 secondary outcome
Live Birth Rate according to stimulation protocol
Time frame: 6 weeks to 42 weeks after embryo transfer
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 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.
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?
Clinical Pregnancy Rate according to stimulation protocol (time frame: 6 weeks to 42 weeks after embryo transfer). The study lists 2 primary outcomes in all. 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.