Mild Versus Conventional Ovarian Stimulation Treatment for In Vitro Fertilization

Subfertility Clinical Trial

— FOLFO  

Official title:

Food Lifestyle and Fertility Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00985062
• Other study ID #: VPG.03.02
• Status: Completed
• Phase: N/A
• First received: September 24, 2009
• Last updated: September 25, 2009
• Start date: October 2004
• Est. completion date: December 2006

Study information

• Verified date: September 2009
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 37 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Subfertility

Intervention

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.
• 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

Locations

Country	Name	City	State
Netherlands	Erasmus Medical Center	Rotterdam	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

References & Publications (5)

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 A — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No