Trial Outcomes & Findings for Gene Expression Profile After Gonadotropin Releasing Hormone (GnRH) Agonist Trigger of Oocyte Maturation (NCT NCT01606709)

Results Overview

Microarray of gene expression in the midluteal phase

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

7 participants

Primary outcome timeframe

7 days after trigger of oocyte maturation

Results posted on

2018-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	GnRH Agonist Trigger Induction of oocyte maturation with GnRH agonist GnRH agonist: GnRH agonist 1mg one dose	hCG Trigger Induction of oocyte maturation with hCG hCG: 5,000 IU one dose
Overall Study STARTED	4	3
Overall Study COMPLETED	4	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GnRH Agonist Trigger n=4 Participants Induction of oocyte maturation with GnRH agonist GnRH agonist: GnRH agonist 1mg one dose	hCG Trigger n=3 Participants Induction of oocyte maturation with hCG hCG: 5,000 IU one dose	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=4 Participants	3 Participants n=3 Participants	7 Participants n=7 Participants
Age, Categorical >=65 years	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants
Sex: Female, Male Female	4 Participants n=4 Participants	3 Participants n=3 Participants	7 Participants n=7 Participants
Sex: Female, Male Male	0 Participants n=4 Participants	0 Participants n=3 Participants	0 Participants n=7 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 7 days after trigger of oocyte maturation

Population: Inadequate RNA quality to completely analyze gene expression

Microarray of gene expression in the midluteal phase

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At baseline and up to 7 days after trigger of oocyte maturation

Population: Too few patients completed survey to meaningfully analyze data

Outcome measures

Outcome data not reported

Adverse Events

GnRH Agonist Trigger

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

hCG Trigger

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lawrence Engmann

UConnHealth

Phone: 8605258283

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place