InfertilityNCT01946022
Evaluation of Granulosa Cells Function After IVF Protocols
A study testing randomization between the two GnRH analogues (agonist and antagonist) in people with Infertility and In Vitro Fertilization Protocols, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
Trial summary
This study is intended to evaluate ovarian cells after being submitted do different in vitro fertilization protocols. The investigators will analyze hormones secretion and intracellular mechanisms of these cells comparing the GnRH agonist protocol and the GnRH antagonist protocol. Read more about this study
- Who is it for?
- Ages 20 to 39 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, In Vitro Fertilization Protocols
- What is being tested?
- randomization between the two GnRH analogues (agonist and antagonist)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesBrazil
- Study dates
- Sep 2013to Oct 2014
- Phase
- Interventional
- 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 39 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patient age limit: 39 years
- Follicle Stimulating Hormone (FSH) < 10 micrometer (mU) / Liter
- Antral follicular count > 12
- Regular menses (25 to 35 days)
- More than 3 oocytes after ovarian punction
- Anti Mullerian between 1 e 3 ng/ml
Who cannot join
- Patients submitted to intracytoplasmatic sperm injection (ICSI)
- Ovarian mass or cyst
- Clinical / endocrine pathologies
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites, 2 recruiting
- Recruiting
Projeto Cegonha
Porto Alegre, Rio Grande do Sul, 90020160
Rita d Chapon, 5192028288, rchapon@gmail.com
Rita Chapon
- Recruiting
Insemine
Porto Alegre, Rio Grande do Sul, 91330001
Rita
Rita Chapon
About this study
Official title: In Vitro Evaluation of Luteinized Granulosa Cells After Being Submitted to in Vitro Fertilization Protocols With Gonadotropin-Releasing Hormone (GnRH) Agonist and GnRH Antagonist
This study is intended to evaluate ovarian cells after being submitted do different in vitro fertilization protocols. The investigators will analyze hormones secretion and intracellular mechanisms of these cells comparing the GnRH agonist protocol and the GnRH antagonist protocol.
- Conditions
- Infertility, In Vitro Fertilization Protocols
- Being tested
- randomization between the two GnRH analogues (agonist and antagonist)
- Keywords
- infertility, ovulation induction, luteal phase, granulosa cells function, GnRH agonist and antagonist, HMG, FSHr
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
randomization between the two GnRH analogues (agonist and antagonist)Drug
| Study group | Role | What they receive |
|---|---|---|
| GnRH Agonist | Active comparator | GnRH long agonist protocol of invitro fertilization Receives: Drug: randomization between the two GnRH analogues (agonist and antagonist) |
| GnRH Antagonist | Active comparator | GnRH fixed antagonist protocol of in vitro fertilization Receives: Drug: randomization between the two GnRH analogues (agonist and antagonist) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of steroid secretion and enzyme expression in in vitro luteinized granulosa cells
evaluation of granulosa cells hormone secretion and enzyme expression in media culture 48 hours after ovarian punction
Measured: after 48h in media culture
Number of retrieved oocytes
Immediately after the ovarian punction the number of retrieved oocytes will be evaluated
Measured: After the ovarian punction
Secondary outcomes (2)
number of embryos
the embryologist will verify the number of embryos after 3 to 5 days from the ovarian punction
Measured: 3 to 5 days after ovarian punction
Subgroup analyses comparing FSH versus HMG protocols
It will be verified the differences between the two types of gonadotrophins in ovarian stimulation regarding: units of gonadotrophins used, number of retrieved oocytes,number of embryos and embryo score
Measured: after ovarian punction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionOct 2014 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946022
- Sponsor's protocol ID
- 13-0120
- Other IDs
- HCPA
- Status last verified
- Nov 2013
- First submitted
- 2 Aug 2013
- Last updated
- 7 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vitro Evaluation of Luteinized Granulosa Cells After Being Submitted to in Vitro Fertilization Protocols With Gonadotropin-Releasing Hormone (GnRH) Agonist and GnRH Antagonist
- ClinicalTrials.gov ID
- NCT01946022
- Acronym / sponsor ID
- 13-0120
- Conditions
- Infertility, In Vitro Fertilization Protocols
- Keywords
- infertility, ovulation induction, luteal phase, granulosa cells function, GnRH agonist and antagonist, HMG, FSHr
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Oct 2014 (estimated)
- First posted
- 19 Sep 2013 (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.
This study is intended to evaluate ovarian cells after being submitted do different in vitro fertilization protocols. The investigators will analyze hormones secretion and intracellular mechanisms of these cells comparing the GnRH agonist protocol and the GnRH antagonist protocol.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GnRH Agonist | Active comparator | Drug: randomization between the two GnRH analogues (agonist and antagonist)GnRH long agonist protocol of invitro fertilization |
| GnRH Antagonist | Active comparator | Drug: randomization between the two GnRH analogues (agonist and antagonist)GnRH fixed antagonist protocol of in vitro fertilization |
Who may qualify
- Ages
- 20 to 39 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patient age limit: 39 years
- Follicle Stimulating Hormone (FSH) < 10 micrometer (mU) / Liter
- Antral follicular count > 12
- Regular menses (25 to 35 days)
- More than 3 oocytes after ovarian punction
Key exclusion criteria (3 listed)
- Patients submitted to intracytoplasmatic sperm injection (ICSI)
- Ovarian mass or cyst
- Clinical / endocrine pathologies
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 |
|---|---|---|
| randomization between the two GnRH analogues (agonist and antagonist) | Drug | GnRH Agonist, GnRH Antagonist |
Primary outcome
Evaluation of steroid secretion and enzyme expression in in vitro luteinized granulosa cells
Time frame: after 48h in media culture
evaluation of granulosa cells hormone secretion and enzyme expression in media culture 48 hours after ovarian punction
Number of retrieved oocytes
Time frame: After the ovarian punction
Immediately after the ovarian punction the number of retrieved oocytes will be evaluated
2 secondary outcomes
number of embryos
Time frame: 3 to 5 days after ovarian punction
Subgroup analyses comparing FSH versus HMG protocols
Time frame: after ovarian punction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2013.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing randomization between the two GnRH analogues (agonist and antagonist) in people with Infertility and In Vitro Fertilization Protocols, run by Hospital de Clinicas de Porto Alegre at 2 sites in Brazil.
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 6 inclusion and 3 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 7 Nov 2013. 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 Brazil. 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 Rita d Chapon (5192028288, rchapon@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of steroid secretion and enzyme expression in in vitro luteinized granulosa cells (time frame: after 48h in media culture). 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 7 Nov 2013.