FOLFO: Mild Versus Conventional Ovarian Stimulation Treatment for In Vitro Fertilization

• Sponsor: Erasmus Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT00985062
• Collaborator: (none)
• Enrollment: 54
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief 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 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.

Condition or Disease	Intervention/Treatment	Phase
Subfertility	Procedure: Mild Ovarian Stimulation Treatment; Procedure: Conventional Ovarian Stimulation Treatment	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Food Lifestyle and Fertility Outcome
• Study Start Date: Oct 1, 2004
• Actual Primary Completion Date: Dec 1, 2006
• Actual Study Completion Date: Dec 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mild Ovarian Stimulation	Procedure: Mild Ovarian Stimulation Treatment; 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	Procedure: Conventional Ovarian Stimulation Treatment; 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

Outcome Measures

Primary Outcome Measures

1. Endocrine, metabolic biomarkers and proteins and Fertility outcome parameters [At menstrual cycle day 2 before stimulation, on the day of hCG administration after stimulation treatment and after embryo transplantation]

Secondary Outcome Measures

1. Homocysteine-methionine cycle biomarker, endocrine and folate levels in serum [At menstrual cycle day 2 before stimulation and on the day of hCG administration after stimulation treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 37 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Erasmus Medical Center	Rotterdam	Zuid-Holland	Netherlands	3015GD

Sponsors and Collaborators

• Erasmus Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Epub 2007 Nov 15. Review.
• Forges T, Pellanda H, Diligent C, Monnier P, Guéant 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. Review. French.
• 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. Review.
• 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. Review.

• ClinicalTrials.gov Identifier: NCT00985062
• Other Study ID Numbers: VPG.03.02
• First Posted: Sep 28, 2009
• Last Update Posted: Sep 28, 2009
• Last Verified: Sep 1, 2009

• Keywords provided by , ,: Folic Acid; Homocysteine; Ovarian response; In Vitro Fertilization
• Additional relevant MeSH terms: Infertility

Study Results

No Results Posted as of Sep 28, 2009