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Traditional Clomiphene Citrate Administration vs. Stair-step Approach (Clomid)

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ClinicalTrials.gov Identifier: NCT01008319
Recruitment Status : Completed
First Posted : November 5, 2009
Results First Posted : January 8, 2018
Last Update Posted : January 8, 2018
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Ovulatory Dysfunction
Anovulation
Ovulation Induction
Intervention Drug: clomiphene citrate
Enrollment 120
Recruitment Details Recruitment was in the infertility clinic.
Pre-assignment Details  
Arm/Group Title Traditional Administration Stair-Step Administration
Hide Arm/Group Description

The traditional approach to ovulation induction with clomiphene citrate involves administration of 50mg/day for five days (starting on cycle day 5). If ovulation does not occur by day 21 then a progestin is prescribed to induce menses (which occurs within one week of stopping the progestin) and then a higher dose of medication is used in the next cycle.

This process will be repeated at increased doses of clomiphene citrate (100 mg and 150 mg).

The stair-step protocol the dose of clomiphene citrate would be increased without administering progestin and inducing a period. This method utilizes ultrasound monitoring for follicle development before increasing the dose of clomiphene citrate.
Period Title: Overall Study
Started 60 60
Completed 60 60
Not Completed 0 0
Arm/Group Title Traditional Administration Stair-Step Administration Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 60 60 120
Hide Baseline Analysis Population Description
A total of 120 patients (60 stair-step, 60 traditional) were randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 120 participants
27.88  (4.95) 29.37  (3.96) 28.65  (4.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
Female
60
 100.0%
60
 100.0%
120
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 120 participants
American Indian or Alaska Native
4
   6.7%
0
   0.0%
4
   3.3%
Asian
4
   6.7%
2
   3.3%
6
   5.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  10.0%
3
   5.0%
9
   7.5%
White
46
  76.7%
55
  91.7%
101
  84.2%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Time to Ovulation With Each Protocol
Hide Description We hypothesized that time to ovulation would be shorter with stair-step protocol vs. traditional.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Traditional Administration Stair-Step Administration
Hide Arm/Group Description:

The traditional approach to ovulation induction with clomiphene citrate involves administration of 50mg/day for five days (starting on cycle day 3, 4, or 5). If ovulation does not occur then a progestin is prescribed to induce menses (which occurs within one week of stopping the progestin) and then a higher dose of medication is used in the next cycle.

clomiphene citrate: Clomiphene citrate 50 mg for 5 days starting on cycle day 5. Transvaginal ultrasound between cycle days 11 to 14 to determine if there is a dominant follicle. If NO dominant follicle present, another ultrasound and blood draw (to test progesterone level) will be done one week later to confirm no response to the medication dose. Medroxyprogesterone acetate (Provera) 10 mg per day for 10 days. Increased dose of clomiphene citrate for 5 days starting on cycle day 5. This process will be repeated at increased doses of clomiphene citrate (100 mg and 150 mg) until a dominant follicle(s) is present.

The stair-step protocol the dose of clomiphene citrate would be increased without administering progestin and inducing a period. This would eliminate the days of progestin (10 days) and the waiting for the period (usually 3 to 7 days) and finally waiting to start clomiphene citrate on cycle day 3 at the earliest (3 more days) for a total of up to 20 days difference for the 100 mg dose of clomid. If they did not ovulate on 100mg, then the process repeats and another 20 days before they start 150mg. Therefore, the time to ovulation and pregnancy may be reduced, and hopefully pregnancy, by using the stair-step protocol. This method utilizes ultrasound monitoring for follicle development before increasing the dose of clomiphene citrate.
Overall Number of Participants Analyzed 60 60
Mean (Standard Error)
Unit of Measure: days
31.1  (3.5) 21.5  (0.9)
2.Secondary Outcome
Title Rate of Ovulation
Hide Description Rate of ovulation with each dose of clomid within each protocol
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Proportion of subjects that ovulated at each dose of Clomid based on which protocol they were randomized to.
Arm/Group Title Traditional Protocol Stair-Step Protocol
Hide Arm/Group Description:
The proportion that ovulated at the dose of Clomid of 60 patients in the traditional protocol.
The proportion that ovulated at the dose of Clomid of 60 patients in the stair-step protocol.
Overall Number of Participants Analyzed 60 60
Measure Type: Count of Participants
Unit of Measure: Participants
Clomid 50mg
45
  75.0%
26
  43.3%
Clomid 100mg
7
  11.7%
18
  30.0%
Clomid 150mg
1
   1.7%
10
  16.7%
Clomid No Response
7
  11.7%
6
  10.0%
3.Secondary Outcome
Title Delivery Outcomes
Hide Description Proportion of participants that delivered a baby based on which protocol they were randomized to.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants randomized to each arm.
Arm/Group Title Traditional Protocol Stair-Step Protocol
Hide Arm/Group Description:
Proportion of subjects that delivered in the traditional protocol.
Proportion of subjects that delivered in the stair-step protocol.
Overall Number of Participants Analyzed 60 60
Measure Type: Count of Participants
Unit of Measure: Participants
21
  35.0%
21
  35.0%
Time Frame [Not Specified]
Adverse Event Reporting Description Questionnaire were administered at each appointment for ultrasound evaluation. They assessed none, mild, moderate or severe symptoms including: hot flashes, mood swings, breast tenderness, pelvic discomfort, nausea, vomiting, blurry vision, light sensitivity, headache, decreased urination, weight gain, insomnia, nervousness and leg pain.
 
Arm/Group Title Traditional Administration Stair-Step Administration
Hide Arm/Group Description

The traditional approach to ovulation induction with clomiphene citrate involves administration of 50mg/day for five days (starting on cycle day 3, 4, or 5). If ovulation does not occur then a progestin is prescribed to induce menses (which occurs within one week of stopping the progestin) and then a higher dose of medication is used in the next cycle.

clomiphene citrate: Clomiphene citrate 50 mg for 5 days starting on cycle day 5. Transvaginal ultrasound between cycle days 11 to 14 to determine if there is a dominant follicle. If NO dominant follicle present, another ultrasound and blood draw (to test progesterone level) will be done one week later to confirm no response to the medication dose. Medroxyprogesterone acetate (Provera) 10 mg per day for 10 days. Increased dose of clomiphene citrate for 5 days starting on cycle day 5. This process will be repeated at increased doses of clomiphene citrate (100 mg and 150 mg) until a dominant follicle(s) is present.

The stair-step protocol the dose of clomiphene citrate would be increased without administering progestin and inducing a period. This would eliminate the days of progestin (10 days) and the waiting for the period (usually 3 to 7 days) and finally waiting to start clomiphene citrate on cycle day 3 at the earliest (3 more days) for a total of up to 20 days difference for the 100 mg dose of clomid. If they did not ovulate on 100mg, then the process repeats and another 20 days before they start 150mg. Therefore, the time to ovulation and pregnancy may be reduced, and hopefully pregnancy, by using the stair-step protocol. This method utilizes ultrasound monitoring for follicle development before increasing the dose of clomiphene citrate.
All-Cause Mortality
Traditional Administration Stair-Step Administration
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Traditional Administration Stair-Step Administration
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/60 (3.33%)      3/60 (5.00%)    
Congenital, familial and genetic disorders     
Birth Defect *  0/60 (0.00%)  0 2/60 (3.33%)  2
Eye disorders     
Blurry Vision/Double Vision *  1/60 (1.67%)  1 1/60 (1.67%)  1
Hepatobiliary disorders     
Gallstones *  1/60 (1.67%)  1 0/60 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Traditional Administration Stair-Step Administration
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   60/60 (100.00%)      60/60 (100.00%)    
Endocrine disorders     
Vasomotor Flushes (hot flashes) * [1]  32/60 (53.33%)  146 30/60 (50.00%)  83
Weight gain *  11/60 (18.33%)  21 6/60 (10.00%)  9
Eye disorders     
Blurry Vision/Double Vision *  6/60 (10.00%)  9 3/60 (5.00%)  3
Light sensitivity *  7/60 (11.67%)  19 1/60 (1.67%)  2
Gastrointestinal disorders     
Nausea *  26/60 (43.33%)  48 15/60 (25.00%)  28
Vomiting *  1/60 (1.67%)  1 1/60 (1.67%)  1
General disorders     
Insomnia *  15/60 (25.00%)  33 7/60 (11.67%)  13
Musculoskeletal and connective tissue disorders     
Leg pain/leg swelling *  4/60 (6.67%)  6 2/60 (3.33%)  2
Nervous system disorders     
Headaches *  34/60 (56.67%)  90 27/60 (45.00%)  53
Psychiatric disorders     
Mood Swings * [2]  32/60 (53.33%)  104 27/60 (45.00%)  67
Nervousness *  12/60 (20.00%)  21 3/60 (5.00%)  4
Renal and urinary disorders     
Decreased urination frequency *  0/60 (0.00%)  0 1/60 (1.67%)  1
Reproductive system and breast disorders     
Breast tenderness *  21/60 (35.00%)  35 21/60 (35.00%)  30
Pelvic Discomfort *  29/60 (48.33%)  75 18/60 (30.00%)  36
*
Indicates events were collected by non-systematic assessment
[1]
Hot Flashes
[2]
mood irritability
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: LaTasha Craig, MD
Organization: University of Oklahoma
Phone: 405-271-8787
EMail: latasha-craig@ouhsc.edu
Layout table for additonal information
Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT01008319    
Other Study ID Numbers: 2078
First Submitted: November 3, 2009
First Posted: November 5, 2009
Results First Submitted: March 29, 2017
Results First Posted: January 8, 2018
Last Update Posted: January 8, 2018