InfertilityNCT00417157
Modified Natural Cycle Offers a Chance of Pregnancy in Patients With Poor Response and High Basal FSH
An observational study of Infertility and Premature Ovarian Failure, run by Eugonia at 1 site in Greece.
Trial summary
The purpose of this study is to evaluate the effectiveness of a modified natural cycle in patients with previous poor response to infertility drugs and high basal FSH, prior to proceeding to oocyte donation or abandoning fertility treatment. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Premature Ovarian Failure
- What is being tested?
- recombinant FSH (Puregon, Organon, The Netherlands), GnRH antag: Ganirelix (Orgalutran, Organon, The Netherlands) and hCG (Pregnyl, Organon, The Netherlands)
- How many people
- 135 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2007to Dec 2012
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women undergoing IVF treatment
Who may be able to join
- Regular menstrual cycle (21-35 days)
- Basal FSH>12 IU/ml
- One or more failed IVF attempts (<3 oocyte retrieved)
Who cannot join
- PCOS
- Normal responders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Successful Application of Modified Natural Cycle in Poor Responders With High Basal FSH Prior to Oocyte Donation
The purpose of this study is to evaluate the effectiveness of a modified natural cycle in patients with previous poor response to infertility drugs and high basal FSH, prior to proceeding to oocyte donation or abandoning fertility treatment.
Read the detailed description
Poor responders are a diverse group of IVF patients who fail to respond to IVF drugs. In these patients pregnancy rates remain disappointingly low and usually oocyte donation is their only viable option. The need for lengthy ovarian stimulation regimes can be avoided by performing IVF during a natural menstrual cycle. However, the main problem with a natural cycle is that successful IVF outcome can be compromised by a premature LH surge. This problem can be solved by the administration of GnRH antagonists that suppress endogenous gonadotropin levels, comprising a modified natural cycle (MNC). Previous studies have shown that MNC offers no realistic chances of pregnancy prior to oocyte donation. In this study we will re-assess this view by showing that MNC offers some, albeit small, chances of positive IVF outcome in patients with known previous poor response prior to oocyte donation.
- Conditions
- Infertility, Premature Ovarian Failure
- Being tested
- recombinant FSH (Puregon, Organon, The Netherlands), GnRH antag: Ganirelix (Orgalutran, Organon, The Netherlands), hCG (Pregnyl, Organon, The Netherlands)
- Keywords
- GnRH antagonist, Poor responders, Oocyte donation, Modified natural cycle
- Medical subject headings
- Infertility, Primary Ovarian Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant FSH (Puregon, Organon, The Netherlands)Drug
GnRH antag: Ganirelix (Orgalutran, Organon, The Netherlands)Drug
hCG (Pregnyl, Organon, The Netherlands)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth per started cycle
Measured: live birth
Secondary outcomes (4)
Biochemical pregnancy per started cycle
Measured: positive hCG test 14 days post oocyte retrieval
Clinical pregnancy per started cycle
Measured: presence of fetal sac and heart beat at 7 weeks of gestation
Cycle cancellation rates
Measured: cycles not reaching oocyte retrieval
Ongoing pregnancy rates per started cycle
Measured: presence of fetal sac and heart beat at 12 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2006 (estimated)
- Study startJan 2007
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eugonia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tryfon Lainas, PhD, Principal investigator, Eugonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417157
- Sponsor's protocol ID
- MNC
- Status last verified
- Dec 2013
- First submitted
- 22 Dec 2006
- Last updated
- 16 Dec 2013
- Results posted
- No
Publications
Kolibianakis E, Zikopoulos K, Camus M, Tournaye H, Van Steirteghem A, Devroey P. Modified natural cycle for IVF does not offer a realistic chance of parenthood in poor responders with high day 3 FSH levels, as a last resort prior to oocyte donation. Hum Reprod. 2004 Nov;19(11):2545-9. doi: 10.1093/humrep/deh452. Epub 2004 Oct 7.
PubMed 15471941
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Successful Application of Modified Natural Cycle in Poor Responders With High Basal FSH Prior to Oocyte Donation
- ClinicalTrials.gov ID
- NCT00417157
- Acronym / sponsor ID
- MNC
- Conditions
- Infertility, Premature Ovarian Failure
- Keywords
- GnRH antagonist, Poor responders, Oocyte donation, Modified natural cycle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- EugoniaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 29 Dec 2006 (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 effectiveness of a modified natural cycle in patients with previous poor response to infertility drugs and high basal FSH, prior to proceeding to oocyte donation or abandoning fertility treatment.
Detailed description
Poor responders are a diverse group of IVF patients who fail to respond to IVF drugs. In these patients pregnancy rates remain disappointingly low and usually oocyte donation is their only viable option. The need for lengthy ovarian stimulation regimes can be avoided by performing IVF during a natural menstrual cycle. However, the main problem with a natural cycle is that successful IVF outcome can be compromised by a premature LH surge. This problem can be solved by the administration of GnRH antagonists that suppress endogenous gonadotropin levels, comprising a modified natural cycle (MNC). Previous studies have shown that MNC offers no realistic chances of pregnancy prior to oocyte donation. In this study we will re-assess this view by showing that MNC offers some, albeit small, chances of positive IVF outcome in patients with known previous poor response prior to oocyte donation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women undergoing IVF treatment
Key inclusion criteria (3 listed)
- Regular menstrual cycle (21-35 days)
- Basal FSH>12 IU/ml
- One or more failed IVF attempts (<3 oocyte retrieved)
Key exclusion criteria (2 listed)
- PCOS
- Normal responders
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 |
|---|---|---|
| recombinant FSH (Puregon, Organon, The Netherlands) | Drug | – |
| GnRH antag: Ganirelix (Orgalutran, Organon, The Netherlands) | Drug | – |
| hCG (Pregnyl, Organon, The Netherlands) | Drug | – |
Primary outcome
Live birth per started cycle
Time frame: live birth
4 secondary outcomes
Biochemical pregnancy per started cycle
Time frame: positive hCG test 14 days post oocyte retrieval
Clinical pregnancy per started cycle
Time frame: presence of fetal sac and heart beat at 7 weeks of gestation
Cycle cancellation rates
Time frame: cycles not reaching oocyte retrieval
Ongoing pregnancy rates per started cycle
Time frame: presence of fetal sac and heart beat at 12 weeks of gestation
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 16 Dec 2013.
- Background: PubMed 15471941Kolibianakis E, Zikopoulos K, Camus M, Tournaye H, Van Steirteghem A, Devroey P. Modified natural cycle for IVF does not offer a realistic chance of parenthood in poor responders with high day 3 FSH levels, as a last resort prior to oocyte donation. Hum Reprod. 2004 Nov;19(11):2545-9. doi: 10.1093/humrep/deh452. Epub 2004 Oct 7.
Related trials for Infertility
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
Active, not recruitingObservational study
Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration
Azoospermia, Nonobstructive, Infertility, Male
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
RecruitingObservational study
Pilot Study of Discarded Blastocysts
Infertility (IVF Patients)
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.
Tryfon Lainas, PhD principal investigator
Eugonia
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 Infertility and Premature Ovarian Failure, run by Eugonia 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 3 inclusion and 2 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 16 Dec 2013. 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?
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?
Live birth per started cycle (time frame: live birth). 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 NCT00417157, which also lists 1 linked publication.
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 16 Dec 2013.