Trial Outcomes & Findings for Follicular Steroid Genesis in Controlled Ovarian Stimulation (NCT NCT02738580)

NCT ID: NCT02738580

Last Updated: 2020-03-03

Results Overview

Compare hormonal blood serum concentrations of progesterone during ovarian stimulation implied in follicular steroidogenesis during a cycle of Controlled Ovarian Stimulation with either r-FSH or HP-HMG.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 112 participants
• Primary outcome timeframe: 21 days
• Results posted on: 2020-03-03

Participant Flow

Participant milestones

Measure	rFSH Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function. COS with GnRH antagonists and rFSH: Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function.	HP-HMG Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG with normal ovarian function. COS with GnRH antagonists and HP-HMG: Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG in women with normal ovarian function.
Overall Study STARTED	56	56
Overall Study COMPLETED	52	52
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Measure	rFSH Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function. COS with GnRH antagonists and rFSH: Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function.	HP-HMG Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG with normal ovarian function. COS with GnRH antagonists and HP-HMG: Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG in women with normal ovarian function.
Overall Study Adverse Event	1	0
Overall Study Lack of Efficacy	3	2
Overall Study Withdrawal by Subject	0	1
Overall Study EXCLUDED FROM DONNOR PROGRAM	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	rFSH n=56 Participants Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function. COS with GnRH antagonists and rFSH: Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function.	HP-HMG n=56 Participants Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG with normal ovarian function. COS with GnRH antagonists and HP-HMG: Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG in women with normal ovarian function.	Total n=112 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=56 Participants	0 Participants n=56 Participants	0 Participants n=112 Participants
Age, Categorical Between 18 and 65 years	56 Participants n=56 Participants	56 Participants n=56 Participants	112 Participants n=112 Participants
Age, Categorical >=65 years	0 Participants n=56 Participants	0 Participants n=56 Participants	0 Participants n=112 Participants
Sex: Female, Male Female	56 Participants n=56 Participants	56 Participants n=56 Participants	112 Participants n=112 Participants
Sex: Female, Male Male	0 Participants n=56 Participants	0 Participants n=56 Participants	0 Participants n=112 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 21 days

Compare hormonal blood serum concentrations of progesterone during ovarian stimulation implied in follicular steroidogenesis during a cycle of Controlled Ovarian Stimulation with either r-FSH or HP-HMG.

Outcome measures

Measure	rFSH n=52 Participants Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function. COS with GnRH antagonists and rFSH: Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function.	HP-HMG n=52 Participants Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG with normal ovarian function. COS with GnRH antagonists and HP-HMG: Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG in women with normal ovarian function.
SERUM PROGSTERONE CONCENTRATION	0.74 ng/mL Interval 0.22 to 1.26	0.45 ng/mL Interval 0.19 to 0.71

PRIMARY outcome

Timeframe: 21 days

NUMBER OF FOLICLES REACHED AND PUNCTURED AFTER CONTROLED OVARIAN STIMULATION

Outcome measures

Measure	rFSH n=52 Participants Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function. COS with GnRH antagonists and rFSH: Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function.	HP-HMG n=52 Participants Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG with normal ovarian function. COS with GnRH antagonists and HP-HMG: Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG in women with normal ovarian function.
OVARIAN RESPONSE	16.5 folicles Interval 9.0 to 24.0	17.5 folicles Interval 9.6 to 25.4

Adverse Events

rFSH

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

HP-HMG

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	rFSH n=56 participants at risk Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function. COS with GnRH antagonists and rFSH: Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function.	HP-HMG n=56 participants at risk Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG with normal ovarian function. COS with GnRH antagonists and HP-HMG: Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG in women with normal ovarian function.
Blood and lymphatic system disorders COAGULATION PANEL ALTERATION	1.8% 1/56 • Number of events 1 • 21 Days Coagulation panel alteration.	0.00% 0/56 • 21 Days Coagulation panel alteration.

Other adverse events

Adverse event data not reported

Additional Information

DR. ERNESTO BOSCH

IVIValencia

Phone: +34 963050900

Email: Ernesto.Bosch@ivirma.com

Results disclosure agreements

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