Fertility DisordersNCT03007043
Genetic Variation in Gonadotropin and Gonadotropin Receptor Genes and Suboptimal Response
An observational study of Fertility Disorders, run by Fundacion Dexeus at 2 sites in 2 countries.
Trial summary
To evaluate the difference in the prevalence of the main FSHR polymorphism (ASN680Ser), as well as other, less studied, gonadotropin polymorphisms between ovarian response groups, following ovarian stimulation Read more about this study
- Who is it for?
- Ages 18 to 38 years, women only
- Conditions the study is for
- Fertility Disorders
- What is being tested?
- blood sample
- How many people
- 364 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Nov 2016to Dec 2019
- 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 38 years
- Women only
- No healthy volunteers
- Adult
Study population: Infertile women undergoing ovarian stimulation
Who may be able to join
- Age between 18-38 years old
- BMI 18-28
- Antral follicle count (AFC) > 9 or Anti-mullerian hormone (AMH) >1.1 ng/ml
- 1st or 2nd ovarian stimulation cycle for IVF/ICSI
- Planned to undergo ovarian stimulation with 150IU of rFSH in a fixed GnRH antagonist protocol
Who cannot join
- Antral follicle count (AFC) <9 and AMH<1.1 ng/ml
- PCOS patients according to the Rotterdam criteria
- Patients undergoing in vitro maturation (IVM)
- Untreated endocrine abnormalities
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Vietnam1 site
Department of Obstetrics and Gynecology, University of Medicine and Pharmacy HCMC, Ho Chi Minh City, Vietnam and Research Center for Genetics and Reproductive Health (CGRH), School of Medicine, Vietnam National University HCMC
Ho Chi Minh City
About this study
Official title: Genetic Variation in Gonadotropin and Gonadotropin Receptor Genes as a Causative Factor of Suboptimal Response Following Ovarian Stimulation for IVF/ICSI. A Prospective Cohort Study
To evaluate the difference in the prevalence of the main FSHR polymorphism (ASN680Ser), as well as other, less studied, gonadotropin polymorphisms between ovarian response groups, following ovarian stimulation
- Conditions
- Fertility Disorders
- Being tested
- blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
| Study group | Role | What they receive |
|---|---|---|
| Normal responders | Normal response following IVF Receives: Other: blood sample | |
| Suboptimal responders | Suboptimal response following IVF Receives: Other: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of the main FSH receptor polymorphism
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionApr 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fertility DisordersStudies 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
- 364 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikolaos Polyzos, Fundacion Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03007043
- Sponsor's protocol ID
- 2016.Polymorphisms_COS
- Status last verified
- Jan 2020
- First submitted
- 28 Dec 2016
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Neves AR, Vuong NL, Blockeel C, Garcia S, Alviggi C, Spits C, Ma PQM, Ho MT, Tournaye H, Polyzos NP. The effect of polymorphisms in FSHR gene on late follicular phase progesterone and estradiol serum levels in predicted normoresponders. Hum Reprod. 2022 Oct 31;37(11):2646-2654. doi: 10.1093/humrep/deac193.
PubMed 36069495Polyzos NP, Neves AR, Drakopoulos P, Spits C, Alvaro Mercadal B, Garcia S, Ma PQM, Le LH, Ho MT, Mertens J, Stoop D, Tournaye H, Vuong NL. The effect of polymorphisms in FSHR and FSHB genes on ovarian response: a prospective multicenter multinational study in Europe and Asia. Hum Reprod. 2021 May 17;36(6):1711-1721. doi: 10.1093/humrep/deab068.
PubMed 33889959
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Variation in Gonadotropin and Gonadotropin Receptor Genes as a Causative Factor of Suboptimal Response Following Ovarian Stimulation for IVF/ICSI. A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03007043
- Acronym / sponsor ID
- 2016.Polymorphisms_COS
- Conditions
- Fertility Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 364 participants (actual)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Apr 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 30 Dec 2016 (estimated)
- 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.
To evaluate the difference in the prevalence of the main FSHR polymorphism (ASN680Ser), as well as other, less studied, gonadotropin polymorphisms between ovarian response groups, following ovarian stimulation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal responders | – | Other: blood sampleNormal response following IVF |
| Suboptimal responders | – | Other: blood sampleSuboptimal response following IVF |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Infertile women undergoing ovarian stimulation
Key inclusion criteria (5 listed)
- Age between 18-38 years old
- BMI 18-28
- Antral follicle count (AFC) > 9 or Anti-mullerian hormone (AMH) >1.1 ng/ml
- 1st or 2nd ovarian stimulation cycle for IVF/ICSI
- Planned to undergo ovarian stimulation with 150IU of rFSH in a fixed GnRH antagonist protocol
Key exclusion criteria (4 listed)
- Antral follicle count (AFC) <9 and AMH<1.1 ng/ml
- PCOS patients according to the Rotterdam criteria
- Patients undergoing in vitro maturation (IVM)
- Untreated endocrine abnormalities
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 |
|---|---|---|
| blood sample | Other | Normal responders, Suboptimal responders |
Primary outcome
prevalence of the main FSH receptor polymorphism
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Derived from this study: PubMed 36069495Neves AR, Vuong NL, Blockeel C, Garcia S, Alviggi C, Spits C, Ma PQM, Ho MT, Tournaye H, Polyzos NP. The effect of polymorphisms in FSHR gene on late follicular phase progesterone and estradiol serum levels in predicted normoresponders. Hum Reprod. 2022 Oct 31;37(11):2646-2654. doi: 10.1093/humrep/deac193.
- Derived from this study: PubMed 33889959Polyzos NP, Neves AR, Drakopoulos P, Spits C, Alvaro Mercadal B, Garcia S, Ma PQM, Le LH, Ho MT, Mertens J, Stoop D, Tournaye H, Vuong NL. The effect of polymorphisms in FSHR and FSHB genes on ovarian response: a prospective multicenter multinational study in Europe and Asia. Hum Reprod. 2021 May 17;36(6):1711-1721. doi: 10.1093/humrep/deab068.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fertility Disorders, run by Fundacion Dexeus at 2 sites in 2 countries.
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 4 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: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain, Vietnam. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of the main FSH receptor polymorphism (time frame: 12 months). 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 NCT03007043, which also lists 2 linked publications.
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 27 Jan 2020.