SubfertilityFOLFONCT00985062
Mild Versus Conventional Ovarian Stimulation Treatment for In Vitro Fertilization
A study testing Mild Ovarian Stimulation Treatment and Conventional Ovarian Stimulation Treatment in people with Subfertility, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
In vitro fertilization (IVF) is an assisted reproductive technique to achieve pregnancy in subfertile couples of which the average success rate is only 25%. Mild ovarian stimulation treatment yields less oocytes, has less adverse effects but has a comparable clinical outcome compared to conventional stimulation… Read more about this study
- Who is it for?
- Ages Up to 37 years
- Conditions the study is for
- Subfertility
- What is being tested?
- Mild Ovarian Stimulation Treatment and Conventional Ovarian Stimulation Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2004to Dec 2006
- 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 Up to 37 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All couples with an indication for IVF/ICSI treatment in the Erasmus Medical Center
Who cannot join
- Prior oocyte donation
- Endometriosis
- Hydrosalpinx
- MESA/PESA
- Age >37
- BMI <18 or >29kg/m2
Show all 12Show fewer
- Menstrual cycle disruptions
- Indication for Intra Cytoplasmic Sperm Injection (ICSI)
- Prior IVF treatment without embryo transplant
- History of recurrent abortion
- Abnormal karyotype of male/female
- Uterine abnormalities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Food Lifestyle and Fertility Outcome
In vitro fertilization (IVF) is an assisted reproductive technique to achieve pregnancy in subfertile couples of which the average success rate is only 25%. Mild ovarian stimulation treatment yields less oocytes, has less adverse effects but has a comparable clinical outcome compared to conventional stimulation treatment. There is high inter- and intra person variability in ovarian response and fertility outcome parameters after stimulation treatment and little is known about explanatory variables herefore.
Nutrition and in particular folate, or its synthetic derivative folic acid, is a B-vitamin which has been widely asssociated with reproductive outcome and subfertility. Therefore, in this study we aim to investigate the influence of preconception nutrition and folic acid use on ovarian response after mild/conventional stimulation treatment and to identify biomarkers in the follicular fluid which can indicate oocyte quality and other fertility outcomes.
- Conditions
- Subfertility
- Being tested
- Mild Ovarian Stimulation Treatment, Conventional Ovarian Stimulation Treatment
- Keywords
- Folic Acid, Homocysteine, Ovarian response, In Vitro Fertilization
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mild Ovarian Stimulation TreatmentProcedure or surgery
Administration of a fixed dose of 150 IU/day rFSH s.c. (Puregon® NV Organon, Oss, The Netherlands) from cycle day 5 onwards. As soon as the leading follicle reached a diameter of 14mm, a GnRH-antagonist (Orgalutran®, NV Organon, Oss, The Netherlands) was administered at 0.25 mg/day s.c.. To induce final oocyte maturation a single s.c. dose of 10.000 IE hCG (Pregnyl®, NV Organon. Oss, The Netherlands) was administered.
Conventional Ovarian Stimulation TreatmentProcedure or surgery
Administration of GnRH agonist Triptorelin (Decapeptyl®, Ferring BV, Hoofddorp, The Netherlands) at 0.1 mg/day s.c., starting on cycle day 21 of the menstrual cycle preceding the actual stimulation cycle. After two weeks of the GnRH regimen, co-treatment with rFSH 225 IU/day s.c. (Puregon®, NV Organon, Oss, The Netherlands) was initiated. To induce final oocyte maturation a single s.c. dose of 10.000 IE hCG (Pregnyl®, NV Organon. Oss, The Netherlands) was administered
| Study group | Role | What they receive |
|---|---|---|
| Mild Ovarian Stimulation | Active comparator | Not described Receives: Procedure: Mild Ovarian Stimulation Treatment |
| Conventional Ovarian Stimulation | Active comparator | Not described Receives: Procedure: Conventional Ovarian Stimulation Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endocrine, metabolic biomarkers and proteins and Fertility outcome parameters
Measured: At menstrual cycle day 2 before stimulation, on the day of hCG administration after stimulation treatment and after embryo transplantation
Secondary outcomes (1)
Homocysteine-methionine cycle biomarker, endocrine and folate levels in serum
Measured: At menstrual cycle day 2 before stimulation and on the day of hCG administration after stimulation treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2009 (estimated)
- Study startOct 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SubfertilityStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00985062
- Sponsor's protocol ID
- VPG.03.02
- Acronym
- FOLFO
- Status last verified
- Sep 2009
- First submitted
- 24 Sep 2009
- Last updated
- 28 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Forges T, Pellanda H, Diligent C, Monnier P, Gueant JL. [Do folates have an impact on fertility?]. Gynecol Obstet Fertil. 2008 Sep;36(9):930-9. doi: 10.1016/j.gyobfe.2008.07.004. Epub 2008 Aug 12. French.
PubMed 18701335Fauser BC, Diedrich K, Devroey P; Evian Annual Reproduction Workshop Group 2007. Predictors of ovarian response: progress towards individualized treatment in ovulation induction and ovarian stimulation. Hum Reprod Update. 2008 Jan-Feb;14(1):1-14. doi: 10.1093/humupd/dmm034. Epub 2007 Nov 15.
PubMed 18006561Verberg MF, Eijkemans MJ, Macklon NS, Heijnen EM, Baart EB, Hohmann FP, Fauser BC, Broekmans FJ. The clinical significance of the retrieval of a low number of oocytes following mild ovarian stimulation for IVF: a meta-analysis. Hum Reprod Update. 2009 Jan-Feb;15(1):5-12. doi: 10.1093/humupd/dmn053.
PubMed 19091754Verberg MF, Macklon NS, Nargund G, Frydman R, Devroey P, Broekmans FJ, Fauser BC. Mild ovarian stimulation for IVF. Hum Reprod Update. 2009 Jan-Feb;15(1):13-29. doi: 10.1093/humupd/dmn056.
PubMed 19091755Baart EB, Martini E, Eijkemans MJ, Van Opstal D, Beckers NG, Verhoeff A, Macklon NS, Fauser BC. Milder ovarian stimulation for in-vitro fertilization reduces aneuploidy in the human preimplantation embryo: a randomized controlled trial. Hum Reprod. 2007 Apr;22(4):980-8. doi: 10.1093/humrep/del484. Epub 2007 Jan 4.
PubMed 17204525
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food Lifestyle and Fertility Outcome
- ClinicalTrials.gov ID
- NCT00985062
- Acronym / sponsor ID
- FOLFO / VPG.03.02
- Conditions
- Subfertility
- Keywords
- Folic Acid, Homocysteine, Ovarian response, In Vitro Fertilization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 28 Sep 2009 (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.
In vitro fertilization (IVF) is an assisted reproductive technique to achieve pregnancy in subfertile couples of which the average success rate is only 25%. Mild ovarian stimulation treatment yields less oocytes, has less adverse effects but has a comparable clinical outcome compared to conventional stimulation treatment. There is high inter- and intra person variability in ovarian response and fertility outcome parameters after stimulation treatment and little is known about explanatory variables herefore.
Nutrition and in particular folate, or its synthetic derivative folic acid, is a B-vitamin which has been widely asssociated with reproductive outcome and subfertility. Therefore, in this study we aim to investigate the influence of preconception nutrition and folic acid use on ovarian response after mild/conventional stimulation treatment and to identify biomarkers in the follicular fluid which can indicate oocyte quality and other fertility outcomes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild Ovarian Stimulation | Active comparator | Procedure: Mild Ovarian Stimulation Treatment |
| Conventional Ovarian Stimulation | Active comparator | Procedure: Conventional Ovarian Stimulation Treatment |
Who may qualify
- Ages
- Up to 37 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All couples with an indication for IVF/ICSI treatment in the Erasmus Medical Center
Key exclusion criteria (12 listed)
- Prior oocyte donation
- Endometriosis
- Hydrosalpinx
- MESA/PESA
- Age >37
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 |
|---|---|---|
| Mild Ovarian Stimulation TreatmentAdministration of a fixed dose of 150 IU/day rFSH s.c. (Puregon® NV Organon, Oss, The Netherlands) from cycle day 5 onwards. As soon as the leading follicle reached a diameter of 14mm, a GnRH-antagonist (Orgalutran®, NV Organon, Oss, The Netherlands) was administered at 0.25 mg/day s.c.. To induce final oocyte maturation a single s.c. dose of 10.000 IE hCG (Pregnyl®, NV Organon. Oss, The Netherlands) was administered. | Procedure or surgery | Mild Ovarian Stimulation |
| Conventional Ovarian Stimulation TreatmentAdministration of GnRH agonist Triptorelin (Decapeptyl®, Ferring BV, Hoofddorp, The Netherlands) at 0.1 mg/day s.c., starting on cycle day 21 of the menstrual cycle preceding the actual stimulation cycle. After two weeks of the GnRH regimen, co-treatment with rFSH 225 IU/day s.c. (Puregon®, NV Organon, Oss, The Netherlands) was initiated. To induce final oocyte maturation a single s.c. dose of 10.000 IE hCG (Pregnyl®, NV Organon. Oss, The Netherlands) was administered | Procedure or surgery | Conventional Ovarian Stimulation |
Primary outcome
Endocrine, metabolic biomarkers and proteins and Fertility outcome parameters
Time frame: At menstrual cycle day 2 before stimulation, on the day of hCG administration after stimulation treatment and after embryo transplantation
1 secondary outcome
Homocysteine-methionine cycle biomarker, endocrine and folate levels in serum
Time frame: At menstrual cycle day 2 before stimulation and on the day of hCG administration after stimulation treatment
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 28 Sep 2009.
- Background: PubMed 18701335Forges T, Pellanda H, Diligent C, Monnier P, Gueant JL. [Do folates have an impact on fertility?]. Gynecol Obstet Fertil. 2008 Sep;36(9):930-9. doi: 10.1016/j.gyobfe.2008.07.004. Epub 2008 Aug 12. French.
- Background: PubMed 18006561Fauser BC, Diedrich K, Devroey P; Evian Annual Reproduction Workshop Group 2007. Predictors of ovarian response: progress towards individualized treatment in ovulation induction and ovarian stimulation. Hum Reprod Update. 2008 Jan-Feb;14(1):1-14. doi: 10.1093/humupd/dmm034. Epub 2007 Nov 15.
- Background: PubMed 19091754Verberg MF, Eijkemans MJ, Macklon NS, Heijnen EM, Baart EB, Hohmann FP, Fauser BC, Broekmans FJ. The clinical significance of the retrieval of a low number of oocytes following mild ovarian stimulation for IVF: a meta-analysis. Hum Reprod Update. 2009 Jan-Feb;15(1):5-12. doi: 10.1093/humupd/dmn053.
- Background: PubMed 19091755Verberg MF, Macklon NS, Nargund G, Frydman R, Devroey P, Broekmans FJ, Fauser BC. Mild ovarian stimulation for IVF. Hum Reprod Update. 2009 Jan-Feb;15(1):13-29. doi: 10.1093/humupd/dmn056.
- Results publication: PubMed 17204525Baart EB, Martini E, Eijkemans MJ, Van Opstal D, Beckers NG, Verhoeff A, Macklon NS, Fauser BC. Milder ovarian stimulation for in-vitro fertilization reduces aneuploidy in the human preimplantation embryo: a randomized controlled trial. Hum Reprod. 2007 Apr;22(4):980-8. doi: 10.1093/humrep/del484. Epub 2007 Jan 4.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mild Ovarian Stimulation Treatment and Conventional Ovarian Stimulation Treatment in people with Subfertility, run by Erasmus Medical Center at 1 site in Netherlands.
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 1 inclusion and 12 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 28 Sep 2009. 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 Netherlands. 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?
Endocrine, metabolic biomarkers and proteins and Fertility outcome parameters (time frame: At menstrual cycle day 2 before stimulation, on the day of hCG administration after stimulation treatment and after embryo transplantation). 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 NCT00985062, which also lists 5 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 28 Sep 2009.