Mild Versus Conventional Ovarian Stimulation Treatment for In Vitro Fertilization (FOLFO)
September 25, 2009 updated by: Erasmus Medical Center
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Zuid-Holland
-
Rotterdam, Zuid-Holland, Netherlands, 3015GD
- Erasmus Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 37 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All couples with an indication for IVF/ICSI treatment in the Erasmus Medical Center
Exclusion Criteria:
- Prior oocyte donation
- Endometriosis
- Hydrosalpinx
- MESA/PESA
- Age >37
- BMI <18 or >29kg/m2
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Mild Ovarian Stimulation
|
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.
|
|
Active Comparator: Conventional Ovarian Stimulation
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
At menstrual cycle day 2 before stimulation, on the day of hCG administration after stimulation treatment and after embryo transplantation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
At menstrual cycle day 2 before stimulation and on the day of hCG administration after stimulation treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Verberg 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.
- 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.
- Fauser 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.
- Verberg 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.
- Baart 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2004
Primary Completion (Actual)
December 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
September 24, 2009
First Submitted That Met QC Criteria
September 25, 2009
First Posted (Estimate)
September 28, 2009
Study Record Updates
Last Update Posted (Estimate)
September 28, 2009
Last Update Submitted That Met QC Criteria
September 25, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VPG.03.02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.