Trial Outcomes & Findings for Cetrotide Treatment Optimization (NCT NCT00866034)

NCT ID: NCT00866034

Last Updated: 2014-03-19

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 617 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2014-03-19

Participant Flow

Recruitment period: September 2009 - July 2011 Six hundred and seventeen women undergoing IVF or ICSI were recruited from the IVF outpatient clinics of 13 fertility centres.

None were excluded before assignment.

Participant milestones

Measure	Early Start CD2 Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.	Late Start CD6 Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
Overall Study STARTED	308	309
Overall Study COMPLETED	292	301
Overall Study NOT COMPLETED	16	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cetrotide Treatment Optimization

Baseline characteristics by cohort

Measure	Early Start CD2 n=308 Participants Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.	Late Start CD6 n=309 Participants Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.	Total n=617 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	308 Participants n=5 Participants	309 Participants n=7 Participants	617 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32.1 years STANDARD_DEVIATION 3.9 • n=5 Participants	32.2 years STANDARD_DEVIATION 4.2 • n=7 Participants	32.2 years STANDARD_DEVIATION 4.0 • n=5 Participants
Sex: Female, Male Female	308 Participants n=5 Participants	309 Participants n=7 Participants	617 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Netherlands	308 participants n=5 Participants	309 participants n=7 Participants	617 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Measure	Early Start CD2 n=308 Participants Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.	Late Start CD6 n=309 Participants Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
Live Birth Rate Per Started Cycle and Live Birth From Cryopreserved Embryos Originating From, and Occurring Within 6 Months of the Initial Treatment Cycle Will be Included in the Total Live Birth Rate Per Started Cycle.	26.7 Cumulative live birth rate (%)	29.9 Cumulative live birth rate (%)

SECONDARY outcome

Timeframe: 2 years

Outcome measures

Measure	Early Start CD2 n=308 Participants Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.	Late Start CD6 n=309 Participants Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
Cumulative Ongoing Pregnancy Rate	27.6 cumulative ongoing pregnancy rate (%)	31.4 cumulative ongoing pregnancy rate (%)

OTHER_PRE_SPECIFIED outcome

Timeframe: 2 years

1. difference in endocrine profile between the 2 arms during the mid and late follicular phase

2. influence of early elevated follicular phase progesterone levels on clinical outcome

Outcome measures

Outcome data not reported

Adverse Events

Early Start CD2

Serious events: 4 serious events

Other events: 20 other events

Deaths: 0 deaths

Late Start CD6

Serious events: 8 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	Early Start CD2 n=308 participants at risk Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.	Late Start CD6 n=309 participants at risk Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
Reproductive system and breast disorders OHSS	1.3% 4/308 • Number of events 4	2.6% 8/309 • Number of events 8

Other adverse events

Measure	Early Start CD2 n=308 participants at risk Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.	Late Start CD6 n=309 participants at risk Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
Reproductive system and breast disorders cancellation due to hyperresponse	2.3% 7/308 • Number of events 7	0.97% 3/309 • Number of events 3
Reproductive system and breast disorders cancellation due to hyporesponse	4.2% 13/308 • Number of events 13	4.9% 15/309 • Number of events 15

Additional Information

Ouijdane Hamdine, MD

UMC Utrecht

Phone: +31-88-7557524

Email: O.Hamdine@umcutrecht.nl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place