Trial Outcomes & Findings for Study Evaluating the Timing of Intrauterine Insemination in Relation to Positive Home Ovulation Prediction Kit (NCT NCT02294773)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

Up to 3 months

Results posted on

2015-12-09

Participant Flow

Patients recruited from two clinical offices from 1/2014 until 9/2015.

Participant milestones

Participant milestones
Measure	Insemination Day Of Positive OPK This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7.	Insemination Day After Positive OPK This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7.
Overall Study STARTED	7	6
Overall Study COMPLETED	7	4
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Insemination Day Of Positive OPK This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7.	Insemination Day After Positive OPK This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7.
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Study Evaluating the Timing of Intrauterine Insemination in Relation to Positive Home Ovulation Prediction Kit

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Insemination Day Of Positive OPK n=7 Participants This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7.	Insemination Day After Positive OPK n=6 Participants This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7.	Total n=13 Participants Total of all reporting groups
Age, Continuous	30.4 years STANDARD_DEVIATION 5.9 • n=5 Participants	29.6 years STANDARD_DEVIATION 3.05 • n=7 Participants	30.1 years STANDARD_DEVIATION 4.8 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	13 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 United States	7 participants n=5 Participants	6 participants n=7 Participants	13 participants n=5 Participants
Body Mass Index	30 kg/m^2 STANDARD_DEVIATION 8.9 • n=5 Participants	25 kg/m^2 STANDARD_DEVIATION 4 • n=7 Participants	27.9 kg/m^2 STANDARD_DEVIATION 7.5 • n=5 Participants
Day 3 Follicle Stimulating Hormone	7.6 mIU/ml STANDARD_DEVIATION 1.7 • n=5 Participants	6.2 mIU/ml STANDARD_DEVIATION 1.9 • n=7 Participants	6.9 mIU/ml STANDARD_DEVIATION 1.8 • n=5 Participants
Anti-mullerian Hormone	3.1 ng/ml STANDARD_DEVIATION 2.2 • n=5 Participants	5.8 ng/ml STANDARD_DEVIATION 0 • n=7 Participants	5.2 ng/ml STANDARD_DEVIATION 2.3 • n=5 Participants
Sperm Concentration	32.6 million sperm/ml STANDARD_DEVIATION 13.9 • n=5 Participants	71.2 million sperm/ml STANDARD_DEVIATION 39.2 • n=7 Participants	39.4 million sperm/ml STANDARD_DEVIATION 30.9 • n=5 Participants
Sperm morphology	5.6 Percent normal STANDARD_DEVIATION 2.3 • n=5 Participants	8.5 Percent normal STANDARD_DEVIATION 2.4 • n=7 Participants	6.2 Percent normal STANDARD_DEVIATION 2.6 • n=5 Participants
Mid-luteal progesterone	21.1 ng/ml STANDARD_DEVIATION 16.4 • n=5 Participants	12.1 ng/ml STANDARD_DEVIATION 4.3 • n=7 Participants	18.6 ng/ml STANDARD_DEVIATION 13.7 • n=5 Participants

PRIMARY outcome

Timeframe: Up to 3 months

Outcome measures

Outcome measures
Measure	Insemination Day Of Positive OPK n=7 Participants This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7.	Insemination Day After Positive OPK n=6 Participants This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7.
Number of Pregnancies Achieved Per Menstrual Cycle.	0 pregnancies per cycle	0 pregnancies per cycle

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to cycle day 35

Outcome measures

Outcome measures
Measure	Insemination Day Of Positive OPK n=7 Participants This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7.	Insemination Day After Positive OPK n=6 Participants This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7.
Per Cycle Pregnancy Rate Based on Infertility Diagnosis	0 pregnancies per cycle	0 pregnancies per cycle

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to cycle day 35

Pregnancy rate will be compared between patients \<35 and \>35 at time of study entry.

Outcome measures

Outcome measures
Measure	Insemination Day Of Positive OPK n=7 Participants This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7.	Insemination Day After Positive OPK n=6 Participants This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7.
Pregnancy Rate Per Female Partner Age Female age < 35	0 pregnancies per cycle	0 pregnancies per cycle
Pregnancy Rate Per Female Partner Age Female age > 35	0 pregnancies per cycle	0 pregnancies per cycle

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to cycle day 35

Comparison of pregnancy rate based on semen morphology of \<4% vs \>4% normal morphology scores.

Outcome measures

Outcome measures
Measure	Insemination Day Of Positive OPK n=7 Participants This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7.	Insemination Day After Positive OPK n=6 Participants This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7.
Pregnancy Rate Per Semen Morphology Score Semen morphology < 4%	0 pregnancies per cycle	0 pregnancies per cycle
Pregnancy Rate Per Semen Morphology Score Semen morphology > 4%	0 pregnancies per cycle	0 pregnancies per cycle

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to cycle day 35

Outcome measures

Outcome measures
Measure	Insemination Day Of Positive OPK n=7 Participants This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7.	Insemination Day After Positive OPK n=6 Participants This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive. Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive. Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7. Letrozole: Patient is to take letrozole during cycle days 3-7.
Pregnancy Rate Per Body Mass Index Category Body mass index normal	0 pregnancies per cycle	0 pregnancies per cycle
Pregnancy Rate Per Body Mass Index Category Body mass index overweight	0 pregnancies per cycle	0 pregnancies per cycle
Pregnancy Rate Per Body Mass Index Category Body mass index obese	0 pregnancies per cycle	0 pregnancies per cycle

Adverse Events

Insemination Day Of Positive OPK

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Insemination Day After Positive OPK

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

Dr. Matt Will or Dr. Lauren Messinger

Midwest Fertility Specialists or St. Vincent Women's Hospital

Phone: 317-415-7528

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place