Mild Versus Conventional Ovarian Stimulation Treatment for In Vitro Fertilization

NCT00985062 | Completed DMC

• 1 other identifier: VPG.03.02
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Subfertility

Keywords

Folic Acid; Homocysteine; Ovarian response; In Vitro Fertilization

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (2)

Mild Ovarian Stimulation

ACTIVE COMPARATOR

Procedure: Mild Ovarian Stimulation Treatment

Conventional Ovarian Stimulation

ACTIVE COMPARATOR

Procedure: Conventional Ovarian Stimulation Treatment

Interventions

Mild Ovarian Stimulation Treatment PROCEDURE

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.

Mild Ovarian Stimulation

Conventional Ovarian Stimulation Treatment PROCEDURE

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

Conventional Ovarian Stimulation

Eligibility Criteria

• Age: Up to 37 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All couples with an indication for IVF/ICSI treatment in the Erasmus Medical Center

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead

Study Sites (1)

Erasmus Medical Center

Rotterdam, South Holland, 3015GD, Netherlands

Location

Related Publications (5)

• 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.

  PMID: 18701335 BACKGROUND

• 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.

  PMID: 18006561 BACKGROUND

• 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.

  PMID: 19091754 BACKGROUND

• 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.

  PMID: 19091755 BACKGROUND

• 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.

  PMID: 17204525 RESULT

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 24, 2009
• First Posted: September 28, 2009
• Study Start: October 1, 2004
• Primary Completion: December 1, 2006
• Study Completion: December 1, 2006
• Last Updated: September 28, 2009

Record last verified: 2009-09

Locations

NL (1)