Trial · Interventional

TerminatedPhase 4Results postedRegistry data

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

Short name LITE

NCTNCT00823472Other idLITE studyOther idCCMO: NL2370504108Other idMETC: 08/233

Open at ClinicalTrials.govAsk about this trial

This trial was stopped early.

Reason given at the registry: Inclusion of the study didn't go as fast as expected. Expect: 234 patients in 1 year in 2 centers. After 1,5 year only 147 patients were recruited.

Results were posted for this trial.

Overview

Status: Terminated
Phase: Phase 4
Enrollment: 147 participants (actual)
Sponsor: UMC Utrecht · Other
Design: Randomized · Open label (no masking)
Countries: 2 countries
Belgium, Netherlands
Start: Jan 2009
Primary completion: Oct 2010
Completion: Oct 2010
First posted: 15 Jan 2009 (estimated)
Last update posted: 29 Jan 2019
Conditions: in Vitro Fertilization · Ovulation Induction

Timeline

1 trial · 1 stopped early · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

200920102011

Ph 4
LITE
NCT00823472
Jan 2009 to Oct 2010
Terminated
Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Mild stimulationDrug

Arms2

Experimental
Start rFSH cycle day 2
Experimental
Start rFSH on cycle day 5

Primary outcomes1

Outcomes the sponsor listed as primary.

Proportion of Top Embryos Per OPU.
Time frame · 1 year
Registry description
Proportion of top embryos per ovum pick-up

Secondary outcomes(1)

Number of Cumulus Oocyte Complexes Obtained
Time frame · one year
Registry description
Number of cumulus oocyte complexes obtained after ovum pick-up

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 1 year

Proportion of Top Embryos Per OPU.

Group	Value (percentage embryos)
Start rFSH Cycle Day 2	51.1
Start rFSH on Cycle Day 5	41.8

Secondary and other outcome results(1)

Secondary outcomeMean· one year

Number of Cumulus Oocyte Complexes Obtained

Group	Value (oocytes)	Spread
Start rFSH Cycle Day 2	9.8	5.4
Start rFSH on Cycle Day 5	8.5	5.7

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Start rFSH Cycle Day 2Start 150IU rFSH s.c. cycle day 2	–	0 / 80	0 / 80
Start rFSH on Cycle Day 5Start 150IU rFSH s.c. cycle day 2=5	–	0 / 67	0 / 67

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 36 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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)

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