Trial Comparing Start Stimulation of Recombinant Follicle Stimulating Hormone (rFSH) on Cycle Day 2 Versus Cycle Day 5 in In Vitro Fertilization (IVF)

in Vitro Fertilization Clinical Trial

— LITE  

Official title:

Among IVF Patients Undergoing Fixed Antagonist Protocols With Recombinant FSH, Does Administration of Recombinant FSH From Cycle Day 5 Onwards Compared With Cycle Day 2 Onwards, Yield a Higher Number of Good Quality Embryos?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00823472
• Other study ID #: LITE study
• Secondary ID: CCMO: NL23705041
• Status: Terminated
• Phase: Phase 4
• Start date: January 2009
• Est. completion date: October 2010

Study information

• Verified date: January 2019
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 147
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 36 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• in Vitro Fertilization
• Ovulation Induction

Intervention

Drug:
• Mild stimulation
Fixed daily dose of 150 IU rFSH start cycle day 5 or day 2 depending on the Arm

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussel
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	Free University Medical Center

Countries where clinical trial is conducted

Belgium,  Netherlands, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Top Embryos Per OPU.	Proportion of top embryos per ovum pick-up	1 year
Secondary	Number of Cumulus Oocyte Complexes Obtained	Number of cumulus oocyte complexes obtained after ovum pick-up	one year