InfertilityPhase 4NCT01353846
Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients
A Phase 4 study testing observation natural cycle and Agonist GnRH; estradiol Valerate; progesterone in people with Infertility, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
Trial summary
The purpose of this study is to compare the natural cycle (without any medication) with the well-established artificial cycle in an egg donation program. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- observation natural cycle and Agonist GnRH; estradiol Valerate; progesterone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSpain
- Study dates
- May 2011to Nov 2012
- Phase
- Phase 4
- 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- infertile females with preserved gonadal function
- ages 18 - 44 years old included
- first oocyte donation cycle
Who cannot join
- BMI: > 28
- recurrent miscarriages (3 or more)
- recurrent of implantation failure
- severe male factor
- important miomas
- > 44 years old
- Problems with the drugs used in the study
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
IVI Valencia
Valencia, Valencia, 46015
Leslie Atkinson, MA, +34963050900, leslie.atkinson@ivi.es
Marcos Ferrando, MD
About this study
The purpose of this study is to compare the natural cycle (without any medication) with the well-established artificial cycle in an egg donation program.
Read the detailed description
Oocyte donation is an assisted reproduction technique well established. In patients with ovarian function, it is necessary to synchronize the cycle of the egg donor with the recipient, usually through endometrial preparation of the recipient by artificial cycle, by administering a GnRH agonist on day 21 of cycle and then administered increasing doses of estrogen therapy to achieve adequate endometrial thickness.
The necessity of synchronization between donors and recipient, has made possible not routinely the natural cycle for oocyte donation.
The investigators have recently introduced oocyte vitrification and it allows us to plan the egg donation in a different way. Now the investigators can previously cryopreserved donor oocytes and at the time that the investigators have a compatible receiver, then, plan the donation In this study it will be possible compare the results of oocyte donation cycles in terms of pregnancy rate, implantation and liveborn, depending on whether the recipient has made an artificial cycle of preparation endometrial or a natural cycle.
- Conditions
- Infertility
- Being tested
- observation natural cycle, Agonist GnRH; estradiol Valerate; progesterone
- Keywords
- oocyte donation program, natural cycle, hormone replacement therapy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation natural cycleOther
Also called Control group with natural menstration cycle.
The patients natural reproductive cycle will be observed and compared to the second arm.
Agonist GnRH; estradiol Valerate; progesteroneDrug
Also called Decapeptyl (IPSEN)3.75 mg., Progynova 1 mg (Bayer Schering Farma), Natural micronized progesterone 400 mg/12 hours
Medications: Agonist GnRH Acetate Triptoreline and Acetate Triptorelina and Estradiol Valerate and Natural micronized progesterone, 400 mg/12 hours vaginal administration
| Study group | Role | What they receive |
|---|---|---|
| Natural cycle | Active comparator | Not described Receives: Other: observation natural cycle |
| Artificial cycle | Active comparator | Drugs: Agonist GnRH Acetate Triptoreline Acetate Triptorelina (Agonist GnRH), 3.75 mg. single dose. Estradiol Valerate, orally Initially 4 pills daily during 4 days, and after increase the dose to 6 mg orally daily.
Natural micronized progesterone, 400 mg/12 hours vaginal administration Receives: Drug: Agonist GnRH; estradiol Valerate; progesterone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preparation and treatment for Assisted Human Reproduction procedures and in the case opf pregnancy, follow up.
Outcome of the study is measured by the pregnancy rates after IVF treatments of both arms.
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 posted16 May 2011 (estimated)
- Study startMay 2011
- Primary completionNov 2012 (estimated)
- Study completionNov 2012 (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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIA
- Sponsor type
- University, hospital or other
- Investigators
- Dra. Pilar Alamá, MDPhD, Study director, IVI Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01353846
- Sponsor's protocol ID
- 0901-C-055-MF
- Status last verified
- Mar 2012
- First submitted
- 10 May 2011
- Last updated
- 2 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients
- ClinicalTrials.gov ID
- NCT01353846
- Acronym / sponsor ID
- 0901-C-055-MF
- Conditions
- Infertility
- Keywords
- oocyte donation program, natural cycle, hormone replacement therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Instituto Valenciano de Infertilidad, IVI VALENCIAUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Nov 2012 (estimated)
- First posted
- 16 May 2011 (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.
The purpose of this study is to compare the natural cycle (without any medication) with the well-established artificial cycle in an egg donation program.
Detailed description
Oocyte donation is an assisted reproduction technique well established. In patients with ovarian function, it is necessary to synchronize the cycle of the egg donor with the recipient, usually through endometrial preparation of the recipient by artificial cycle, by administering a GnRH agonist on day 21 of cycle and then administered increasing doses of estrogen therapy to achieve adequate endometrial thickness.
The necessity of synchronization between donors and recipient, has made possible not routinely the natural cycle for oocyte donation.
The investigators have recently introduced oocyte vitrification and it allows us to plan the egg donation in a different way. Now the investigators can previously cryopreserved donor oocytes and at the time that the investigators have a compatible receiver, then, plan the donation In this study it will be possible compare the results of oocyte donation cycles in terms of pregnancy rate, implantation and liveborn, depending on whether the recipient has made an artificial cycle of preparation endometrial or a natural cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural cycle | Active comparator | Other: observation natural cycle |
| Artificial cycle | Active comparator | Drug: Agonist GnRH; estradiol Valerate; progesteroneDrugs: Agonist GnRH Acetate Triptoreline Acetate Triptorelina (Agonist GnRH), 3.75 mg. single dose. Estradiol Valerate, orally Initially 4 pills daily during 4 days, and after increase the dose to 6 mg orally daily. Natural micronized progesterone, 400 mg/12 hours vaginal administration |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- infertile females with preserved gonadal function
- ages 18 - 44 years old included
- first oocyte donation cycle
Key exclusion criteria (7 listed)
- BMI: > 28
- recurrent miscarriages (3 or more)
- recurrent of implantation failure
- severe male factor
- important miomas
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 |
|---|---|---|
| observation natural cycleAlso: Control group with natural menstration cycle.The patients natural reproductive cycle will be observed and compared to the second arm. | Other | Natural cycle |
| Agonist GnRH; estradiol Valerate; progesteroneAlso: Decapeptyl (IPSEN)3.75 mg., Progynova 1 mg (Bayer Schering Farma), Natural micronized progesterone 400 mg/12 hoursMedications: Agonist GnRH Acetate Triptoreline and Acetate Triptorelina and Estradiol Valerate and Natural micronized progesterone, 400 mg/12 hours vaginal administration | Drug | Artificial cycle |
Primary outcome
Preparation and treatment for Assisted Human Reproduction procedures and in the case opf pregnancy, follow up.
Time frame: 12 months
Outcome of the study is measured by the pregnancy rates after IVF treatments of both arms.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2012.
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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.
Dra. Pilar Alamá, MDPhD study director
IVI Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing observation natural cycle and Agonist GnRH; estradiol Valerate; progesterone in people with Infertility, run by Instituto Valenciano de Infertilidad, IVI VALENCIA at 1 site in Spain.
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 3 inclusion and 7 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 2 Apr 2012. 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 Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Dra. Pilar Alamá (+34963050900, pilar.alama@ivi.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preparation and treatment for Assisted Human Reproduction procedures and in the case opf pregnancy, follow up. (time frame: 12 months). 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 2 Apr 2012.