NCT00823472

Brief Summary

Background of the study: Milder stimulation protocols have the advantage of being less expensive and more patient-friendly. Moreover, recent evidence suggests that mild stimulation protocols lead to lower embryo aneuploidy rates compared to conventional treatment regimens. Although with mild stimulation protocols the expected number of oocytes retrieved will be lower, pregnancy rates have shown to be similar possibly because embryo quality outfavours embryo quantity. Objective of the study: The aim of the study is to determine whether cycle day (CD) 5 start of stimulation will lead to better quality of embryos, based on morphology, than CD 2 start, in IVF with GnRH antagonist co-treatment started on a fixed day. Study design: Prospective randomized trial comparing two different starting days of ovarium stimulation (day 2 versus day 5) for IVF treatment. Intervention: One group wil start on cycle day 2 with stimulation of the ovaries with recombinant FSH. The other group will start on cycle day 5. Both group will start suppressing the gonadotrophin production of the the pituitary gland on cycle day 6 with a GnRH antagonist. Primary study parameters/outcome of the study: Primary outcome parameter is number of top embryos per ovum pick up. Secondary study parameters/outcome of the study: Secondary outcome measures are duration of stimulation, cancellation rate, fertilization rate, number of cumulus oocyte complexes obtained, number of mature oocytes obtained, number of top embryos per started cycle, amount of IU recFSH, and clinical pregnancy rate.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2009

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
2 months until next milestone

Results Posted

Study results publicly available

December 2, 2010

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

1.7 years

First QC Date

January 13, 2009

Results QC Date

November 2, 2010

Last Update Submit

January 7, 2019

Conditions

in Vitro FertilizationOvulation Induction

Keywords

embryonic structuressperm injections, intracytoplasmicIVFGnRH antagonistovarian stimulationcycle day 2 versus cycle day 5

Outcome Measures

Primary Outcomes (1)

  • Proportion of Top Embryos Per OPU.

    Proportion of top embryos per ovum pick-up

    1 year

Secondary Outcomes (1)

  • Number of Cumulus Oocyte Complexes Obtained

    one year

Study Arms (2)

Start rFSH cycle day 2

EXPERIMENTAL
Drug: Mild stimulation

Start rFSH on cycle day 5

EXPERIMENTAL
Drug: Mild stimulation

Interventions

Mild stimulationDRUG

Fixed daily dose of 150 IU rFSH start cycle day 5 or day 2 depending on the Arm

Also known as: Puregon, Ganirelix
Start rFSH cycle day 2Start rFSH on cycle day 5

Eligibility Criteria

Age18 Years - 36 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female age \< 36 years
  • FSH \< 12 IU/l
  • BMI 18-29 kg/m2
  • Regular cycle (25-35 days)
  • No major uterine or ovarian abnormalities
  • No previous IVF cycles
  • Written informed consent

You may not qualify if:

  • Oocyte donation
  • Medical contra indication for pregnancy or IVF treatment
  • Endometriosis ≥ grade 3
  • Polycystic Ovarium Syndrome (PCOS)
  • Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UZ Brussel

Brussels, 1090, Belgium

Location

University Medical Center Utrecht

Utrecht, 3508 GA, Netherlands

Location

Related Publications (1)

  • Hohmann FP, Macklon NS, Fauser BC. A randomized comparison of two ovarian stimulation protocols with gonadotropin-releasing hormone (GnRH) antagonist cotreatment for in vitro fertilization commencing recombinant follicle-stimulating hormone on cycle day 2 or 5 with the standard long GnRH agonist protocol. J Clin Endocrinol Metab. 2003 Jan;88(1):166-73. doi: 10.1210/jc.2002-020788.

    PMID: 12519847BACKGROUND

MeSH Terms

Interventions

follitropin betaganirelix

Limitations and Caveats

Early termination of the trial lead to small number of subjects to be analyzed. Only half of the expected patients were included.

Results Point of Contact

Title
Prof. dr. B.C.J.M. Fauser
Organization
UMC Utrecht
b.c.fauser@umcutrecht.nl
+31-88-7557524

Study Officials

  • Bart C Fauser, Prof, PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2009

First Posted

January 15, 2009

Study Start

January 1, 2009

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

January 29, 2019

Results First Posted

December 2, 2010

Record last verified: 2019-01

Locations

BE(1)NL(1)