Clinical trial NCT00985062: Mild Versus Conventional Ovarian Stimulation Treatment for In Vitro Fertilization
Official title: Food Lifestyle and Fertility Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subfertility
Keywords: Folic Acid
Homocysteine
Ovarian response
In Vitro Fertilization
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2009-09-28
Enrollment: 54
Sex: ALL
Maximum age (years): 37
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Endocrine, metabolic biomarkers and proteins and Fertility outcome parameters
timeFrame: At menstrual cycle day 2 before stimulation, on the day of hCG administration after stimulation treatment and after embryo transplantation
Secondary outcomes:
measure: Homocysteine-methionine cycle biomarker, endocrine and folate levels in serum
timeFrame: At menstrual cycle day 2 before stimulation and on the day of hCG administration after stimulation treatment
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
Study officials:
References:
citation: 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.
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. doi: 10.1093/humupd/dmm034. Epub 2007 Nov 15.
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.
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.
citation: 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.