INFERTILITYNCT01645241
Evolutive Potential of Embryos Obtained From Oocytes After Luteal Phase Ovarian Stimulation
A study testing gonadotropins plus GnRH antagonists and ganirelix in people with INFERTILITY and Fertility Preservation, run by Fundacion Dexeus at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the clinical pregnancy rate per embryo transfer in oocytes recipients obtained after ovarian stimulation during the luteal phase of oocytes donors . Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- INFERTILITY, Fertility Preservation, Ovulation Induction
- What is being tested?
- gonadotropins plus GnRH antagonists and ganirelix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2012to Dec 2013
- 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 18 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- premenopausal women, 18-35 years old, FSH levels < 10 mIU/ml; AFC> 10
- regular cycles
- BMI < 28
- signed informed consent
- Recipients:
- Infertile women eligible for oocytes donation
- BMI < 35
- Signed informed consent form
Who cannot join
- -Polycystic ovarian syndrome, gonadotropins allergy
- Recipients:
- Women eligible for oocytes donation
- BMI >35
- Uncontrolled Endocrine Pathology
Trial locations and contacts
1 site in 1 country.
Spain1 site
Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus
Barcelona, Barcelona, 08037
About this study
The purpose of this study is to evaluate the clinical pregnancy rate per embryo transfer in oocytes recipients obtained after ovarian stimulation during the luteal phase of oocytes donors . This study will be performed in egg recipients and donors but this type of treatment is meant to be implemented in fertility preservation patients
- Being tested
- gonadotropins plus GnRH antagonists, ganirelix
- Keywords
- Ovarian stimulation, Luteal phase, Egg donors, Fertility preservation
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gonadotropins plus GnRH antagonistsDrug
Also called Ovarian stimulation
ganirelixDrug
Also called the investigators will administer in the 13th-15th cycle day simultaneously 0.25 mg/day of ganirelix
| Study group | Role | What they receive |
|---|---|---|
| Lutheal phase ovarian stimulation | Experimental | Early luteal phase Controlled ovarian hyperstimulation: we will administer in the 13th-15th cycle day simultaneously 0.25 mg/day of ganirelix to induce luteolysis and FSHr (dose according to BMI and AFC )IU/day for controlled ovarian hyperstimulation until achieving criteria for hCG , to induce final oocyte maturation. Mature oocytes will be vitrified. After warming, oocytes will be inseminated by ICSI with the recipients partners semen sample . Recipient endometrium will be primed with estrogen and progesterone , and embryo transfer will be performed on the 3rd day 3 of embryo cleavage. Receives: Drug: gonadotropins plus GnRH antagonists; Drug: ganirelix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Measured: six weeks after transfer procedure
Secondary outcomes (1)
Number of Mature oocytes
Measured: Day of oocyte retrieval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Collaborators
- FUNDACION DEXEUS SALUT DE LA DONA, Ayudas Merck Serono de Investigación 2012
- Investigators
- Francisca Martínez, PhD, Principal investigator, Fundación Dexeus Salut de la Dona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01645241
- Sponsor's protocol ID
- DEX005
- Status last verified
- Mar 2013
- First submitted
- 18 Jul 2012
- Last updated
- 27 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Sonmezer M, Turkcuoglu I, Coskun U, Oktay K. Random-start controlled ovarian hyperstimulation for emergency fertility preservation in letrozole cycles. Fertil Steril. 2011 May;95(6):2125.e9-11. doi: 10.1016/j.fertnstert.2011.01.030. Epub 2011 Feb 3.
PubMed 21292255von Wolff M, Thaler CJ, Frambach T, Zeeb C, Lawrenz B, Popovici RM, Strowitzki T. Ovarian stimulation to cryopreserve fertilized oocytes in cancer patients can be started in the luteal phase. Fertil Steril. 2009 Oct;92(4):1360-1365. doi: 10.1016/j.fertnstert.2008.08.011. Epub 2008 Oct 18.
PubMed 18930226Martinez F, Clua E, Devesa M, Rodriguez I, Arroyo G, Gonzalez C, Sole M, Tur R, Coroleu B, Barri PN. Comparison of starting ovarian stimulation on day 2 versus day 15 of the menstrual cycle in the same oocyte donor and pregnancy rates among the corresponding recipients of vitrified oocytes. Fertil Steril. 2014 Nov;102(5):1307-11. doi: 10.1016/j.fertnstert.2014.07.741. Epub 2014 Aug 22.
PubMed 25154677
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolutive Potential of Embryos Obtained From Oocytes After Luteal Phase Ovarian Stimulation
- ClinicalTrials.gov ID
- NCT01645241
- Acronym / sponsor ID
- DEX005
- Keywords
- Ovarian stimulation, Luteal phase, Egg donors, Fertility preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Collaborators
- FUNDACION DEXEUS SALUT DE LA DONA, Ayudas Merck Serono de Investigación 2012
- Study start
- Jul 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Jul 2012 (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 evaluate the clinical pregnancy rate per embryo transfer in oocytes recipients obtained after ovarian stimulation during the luteal phase of oocytes donors . This study will be performed in egg recipients and donors but this type of treatment is meant to be implemented in fertility preservation patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lutheal phase ovarian stimulation | Experimental | Drug: gonadotropins plus GnRH antagonists, Drug: ganirelixEarly luteal phase Controlled ovarian hyperstimulation: we will administer in the 13th-15th cycle day simultaneously 0.25 mg/day of ganirelix to induce luteolysis and FSHr (dose according to BMI and AFC )IU/day for controlled ovarian hyperstimulation until achieving criteria for hCG , to induce final oocyte maturation. Mature oocytes will be vitrified. After warming, oocytes will be inseminated by ICSI with the recipients partners semen sample . Recipient endometrium will be primed with estrogen and progesterone , and embryo transfer will be performed on the 3rd day 3 of embryo cleavage. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- premenopausal women, 18-35 years old, FSH levels < 10 mIU/ml; AFC> 10
- regular cycles
- BMI < 28
- signed informed consent
- Infertile women eligible for oocytes donation
Key exclusion criteria (5 listed)
- -Polycystic ovarian syndrome, gonadotropins allergy
- Women eligible for oocytes donation
- BMI >35
- Uncontrolled Endocrine Pathology
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 |
|---|---|---|
| gonadotropins plus GnRH antagonistsAlso: Ovarian stimulation | Drug | Lutheal phase ovarian stimulation |
| ganirelixAlso: the investigators will administer in the 13th-15th cycle day simultaneously 0.25 mg/day of ganirelix | Drug | Lutheal phase ovarian stimulation |
Primary outcome
Pregnancy rate
Time frame: six weeks after transfer procedure
1 secondary outcome
Number of Mature oocytes
Time frame: Day of oocyte retrieval
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 Oct 2014.
- Background: PubMed 21292255Sonmezer M, Turkcuoglu I, Coskun U, Oktay K. Random-start controlled ovarian hyperstimulation for emergency fertility preservation in letrozole cycles. Fertil Steril. 2011 May;95(6):2125.e9-11. doi: 10.1016/j.fertnstert.2011.01.030. Epub 2011 Feb 3.
- Background: PubMed 18930226von Wolff M, Thaler CJ, Frambach T, Zeeb C, Lawrenz B, Popovici RM, Strowitzki T. Ovarian stimulation to cryopreserve fertilized oocytes in cancer patients can be started in the luteal phase. Fertil Steril. 2009 Oct;92(4):1360-1365. doi: 10.1016/j.fertnstert.2008.08.011. Epub 2008 Oct 18.
- Derived from this study: PubMed 25154677Martinez F, Clua E, Devesa M, Rodriguez I, Arroyo G, Gonzalez C, Sole M, Tur R, Coroleu B, Barri PN. Comparison of starting ovarian stimulation on day 2 versus day 15 of the menstrual cycle in the same oocyte donor and pregnancy rates among the corresponding recipients of vitrified oocytes. Fertil Steril. 2014 Nov;102(5):1307-11. doi: 10.1016/j.fertnstert.2014.07.741. Epub 2014 Aug 22.
- Related InfoLink provided by the sponsor.
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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.
Francisca Martínez, PhD principal investigator
Fundación Dexeus Salut de la Dona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gonadotropins plus GnRH antagonists and ganirelix in people with INFERTILITY and Fertility Preservation, run by Fundacion Dexeus 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 8 inclusion and 5 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 Oct 2014. 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.
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?
Pregnancy rate (time frame: six weeks after transfer procedure). 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 NCT01645241, which also lists 3 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 Oct 2014.